Methiod of manufacturing an implantable electrode array by forming  packages around the array control modules after the control modules are bonded to substrates

ABSTRACT

A method of forming an implantable electrode array that includes one or more packaged control modules. A control module is packaged by mounting the module to a substrate and forming a containment ring around the module. A conformal coating is disposed over the surface of the module to cover the carrier. Within the containment ring, the conformal coating hardens to form a non-porous shell around the control module. The one or more packaged control modules are placed in a flexible array. Electrodes that are mounted to or embedded in the flexible carrier are connected to the one or more control modules.

RELATIONSHIP TO EARLIER FILED APPLICATIONS

This application is a divisional of Application This application is adivisional of U.S. patent application Ser. No. 14/045,915 filed 4 Oct.2013. Application Ser. No. 14/045,914 is a divisional of U.S. patentapplication Ser. No. 13/364,973 filed 2 Feb. 2012, now U.S. Pat. No.8,554,340. Application Ser. No. 13/364,973 is a continuation of PCT App.No. PCT/US2010/044401 filed 4 Aug. 2010. PCT App. No. PCT/US2010/044401is a continuation-in-part of U.S. patent application Ser. No. 12/535,717filed 5 Aug. 2009 now U.S. Pat. No. 8,781,600. The contents of the aboveapplications are explicitly incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates generally to an implantable electrode arrayassembly and, more particularly, to an implantable electrode arrayassembly with one or more control modules for regulating the operationof the assembly embedded in the carrier that supports the electrodes.

BACKGROUND OF THE INVENTION

There are a number of medical conditions for which it has been foundthat an effective therapy involves driving current through a section ofthe tissue of a patient. Often, the current is driven between theelectrodes of an electrode array implanted in the patient. Generally,the electrode array includes a non-conductive carrier on which typicallytwo or more electrodes are disposed. Once the electrode array isimplanted, current is driven from at least one of the electrodes,through the adjacent tissue, to at least one of the other electrodes.The current flow through the tissue influences the tissue to accomplisha desired therapeutic result. For example, an electrode array positionedadjacent the heart may flow currents to stimulate the appropriatecontraction and expansion of the heart muscles.

There is an increasing interest in implanting electrode arrays adjacentneural tissue so that the resultant current flow induces a desiredneurological or physical effect. In one known application, the currentdriven between the electrodes of an array placed on top of the dura inthe vertebral column reduces the extent to which chronic pain signalsare perceived by the brain. Alternatively, the array may be placed in alocation where the current flow stimulates a feeling of satiation aspart of an appetite suppression/weight management therapy. In anotherapplication, the current is flowed to tissue or nerves associated withthe bladder or the anal sphincter to assist in control of incontinence.Electrodes may be implanted in a paralysis victim to provide musclecontrol and/or a sense of feeling.

The Applicants' PCT Patent Application No. No. PCT/US2009/33769,FOLDABLE, IMPLANTABLE ELECTRODE ARRAY ASSEMBLY AND TOOL FOR IMPLANTINGSAME, filed 11 Feb. 2009, published as WO 2009/11142, the contents ofwhich are explicitly incorporated herein by reference, describes anelectrode array that includes a carrier on which plural electrodes arearranged in a row by column matrix. An advantage of this electrode arrayis that it allows current to be flowed between numerous differentcombinations of electrodes. Depending on which electrodes are connectedto associated current sources and sinks, this array can be operated sothat there are two or more current flows occurring simultaneouslybetween different sets of electrodes. Once this assembly is deployed,the practitioner can initially drive current between differentcombinations of electrodes. Current therefore flows through differentsections of tissue. This allows the practitioner to determine betweenwhich electrodes, through which tissue, the current flow offers thegreatest benefit and/or tolerable side effects. Once the optimal currentflow path between the electrodes is determined, the array and itsassociated power supply are set to operate in this state.

The Applicants' PCT Patent Application METHOD OF ASSEMBLING AN ELECTRODEARRAY THAT INCLUDES A PLASTICALLY DEFORMABLE CARRIER, filed 29 May 2009,published as PCT Pub. No. WO 2009/155084, the contents of which areexplicitly incorporated herein by reference, describes a means of batchassembling the above-described electrode array.

In comparison to other electrode arrays with lesser numbers ofelectrodes, the above-described array makes it possible to flow currentthrough more sections of tissue and to selectively focus/diffuse thecurrent flow. In contrast to an electrode array with a smaller number ofelectrodes, use of the above-described array increases the likelihoodthat the current flow can be set to provide desired therapeutic effects,with tolerable side effects.

Still another advantage of the above-described array is that the carrieris formed from superelastic material. A superelastic material is onethat, after being subjected to appreciable bending or folding, returnsto its initial state. Thus, once this electrode array is formed, theassembly is then folded or rolled into a form that has a side-to-sidewidth appreciably less than its width in the unfolded/unrolled state. Abenefit of an electrode array assembly of this design is that it can befolded into a sheath. The sheath-encased electrode array assembly canthen be inserted through an access cannula using a minimally invasiveprocedure into the patient. Once in the patient, the sheath and assemblyare steered to over the tissue against which the electrodes integralwith the assembly are deployed. Once the assembly is properlypositioned, the sheath is opened up or removed. The opening/removal ofthe sheath causes the carrier to unfold. As a consequence of the carrierunfolding, the electrodes deploy over the target tissue. A more completeunderstanding of how the electrode array assembly can be so positionedand deployed is contained in the Applicants' Assignee's PCT App. No.PCT/US2010/029628, DELIVERY ASSEMBLY FOR PERCUTANEOUSLY DELIVERING ANDDEPLOYING AN ELECTRODE ARRAY AT A TARGET LOCATION, THE ASSEMBLY CAPABLEOF STEERING THE ELECTRODE ARRAY TO THE TARGET LOCATION, which isexplicitly incorporated herein by reference the contents of which arepublished in US Pat. Pub. No. US 2012/0022551 A1.

Thus, not only does an electrode array built on a superelastic carrierprovide a means for selectively flowing current through differentsections of tissue, the assembly can be placed over the target tissuewithout having to cut a large incision in the patient.

One feature of the above-described array is that also mounted to thecarrier are one or more drive modules. The drive modules contain thecomponents that source/sink the current to/from the electrodes. It isnecessary to provide some on array control circuitry because the arraytypically includes 10 or more and often 20 or more electrodes each ofwhich serve as a current source and/or sink. Without providing thesemodules, it would be necessary to implant a large number of conductorsthat extend from the pulse generator, through the patient, over whichthe current is sourced/sunk to the individual electrodes. Physicalconstraints make it difficult to implant large numbers of conductors inthe patient. The above referenced applications described how anelectrode array may be constructed so that the drive module is disposedon the surface of the array on which the electrodes are disposed; thesurface of the assembly disposed against the tissue. Alternatively, thedrive module may be positioned on the surface of the carrier oppositethe surface that faces the tissue.

Regardless of the location on the surface of the carrier on which thedrive module is located, it is necessary to encase the module in somesort of package. The package protects the semi-conductor die forming thedrive module. Often the package includes a shell and a cap. The shellsurrounds one end and the sides of the die. The cap covers the exposedend of the array and the perimeter of the shell. Consequently, the knownassemblies have some sort of conductors that extend from the electrodes,through the package to the semiconductor die. As mentioned above, asignificant feature of the known assembly is that the carrier has somedegree of flexibility. Accordingly, the conductors disposed on thecarrier of this assembly are subjected to some flexing. Inside thepackage, the conductors are held rigid. Accordingly around the perimeterof the package, where the conductors are stopped from flexing, theconductors may be subjected to considerable stress. There is a concernthat this stress could induce failure in the conductors.

Moreover, inside the package, wire bonds may have to be used toestablish the final connections between the conductors and thecomplementary bond pads on the control module-forming semiconductor die.These wire bonds, given the fragility of the wires from which they areformed, may also be prone to breakage. In regard to this matter isshould be appreciated that once electrode array assembly is implanted,the assembly, like the patient in which it is implanted, is almostalways moving. Over time, the vibration induced by this movement canpotentially cause these wire bonds to fracture. Clearly, the failure ofthese wire bonds, or complementary conductors can result in malfunctionof electrode array.

SUMMARY OF THE INVENTION

This invention is related to a new and useful electrode array designedfor implantation into a living being. The electrode array of thisinvention includes one or more control modules that are built into thearray so as to minimize the extent to which the conductors that extendto the module/modules are subjected to breakage-inducing stress.

The electrode array of this invention includes a carrier. Typically thecarrier is formed out of material that is at least flexible so that thecarrier at least conforms to the tissue against which the array isdeployed. Often the carrier is formed from material that, in addition tobeing flexible, has some degree of elasticity. This allows the electrodearray assembly to be deployed using minimally invasive surgicaltechniques.

The electrode array of this invention also includes one or more controlmodules. A control module is a semiconductor die. The componentsfabricated on the control module source/sink current to one or more ofthe electrodes. Each control module is seated in a window or a recessformed in carrier. In many versions of the invention, a layer ofbiocompatible material surrounds one or more of the exposed faces of thecontrol module to serve as a partial package around the module.Insulating material that has some degree of flexibility is disposed overthe exposed surfaces of the carrier and adjacent exposed surfaces of themodule/modules. Vias extend through the insulating material tocomplementary bond pads on the control module/modules. Some of the viasextend to the individual electrodes. Other ones of the vias extend toconductors also part of the array. These conductors, and the vias towhich they are connected, function as the conductive members throughwhich power and/or operating instructions that originate off the arrayare applied to the control module/modules.

In some versions of the invention, a control module is associated witheach electrode. The control module may be seated in a window or otheropening in the carrier so as to be below the electrode.

The vias and conductors of the electrode array of this invention areprimarily disposed on or extend through layers of material that has somedegree of flexibility. The vias themselves are relatively short inlength. The conductors to which the vias extend are thin both in theirheight and width. These dimensional features of the vias and on-arrayconductors improve their flexibility. Collectively, the flexibility ofthese components, the insulating material, the vias and the conductors,reduces the extent to which the mechanical stress to which the vias andconductors are exposed can cause their breakage.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is pointed out with particularity in the claims. The aboveand further features and advantages of this invention are betterunderstood from the below Detailed Description taken in conjunction withthe accompanying drawings in which:

FIG. 1 is plan view of an electrode array assembly of this invention;

FIG. 1A is an enlarged view of a section of the electrode array of FIG.1;

FIG. 2 is a cross sectional view of a portion of the electrode arrayassembly showing a single electrode and the control module associatedwith that electrode;

FIG. 3 is a block diagram of how signals are distributed to theindividual control modules of the array over a bus;

FIG. 4 depicts the components of a control packet distributed over thebus;

FIGS. 5 and 6 are cross sectional view depicting initial steps of thefabrication of an electrode array assembly on a support substrate;

FIG. 7 is a top plan view of a partially fabricated control module shellof the electrode array assembly;

FIG. 7A is a top plan view of control module seated in the shell;

FIGS. 8-25 are a sequence of cross sectional views depicting thefabrication how an electrode and associated control module of anelectrode array are, according to this invention, fabricated on a wafer;

FIG. 26 is a plane view of a section of a coupon on which a carrier ofthis invention is formed;

FIG. 26A is an enlarged plan view of the distal end of the carrier ofFIG. 26;

FIGS. 27 and 28 are cross sectional views depicting how the carrier isprepared for bonding to a substrate;

FIGS. 29 and 30 are cross sectional views depicting how the substrate isprepared to receive the carrier;

FIGS. 31 and 32 depict how the carrier, once bonded to the substrate, isprepared to receive the electrode-control module-conductor sub-assembly;

FIG. 33 depicts how the seating of the electrode-controlmodule-conductor assembly on the carrier;

FIGS. 34-36 are cross sectional views depicting the steps executed toseparate the electrode array carrier from the adjacent section of thecoupon to which the carrier was connected;

FIG. 37 depicts the lift off, the separation, of the electrode arrayfrom the substrate to which the array carrier was bonded;

FIGS. 38-48 are a sequence of cross sectional views that depict analternative process for assembling an electrode array of this invention;

FIG. 49 is a cross sectional view of a single electrode and controlmodule of a first alternative electrode array of this invention;

FIG. 50 is a block diagram of how signals are distributed to the controlmodules of the electrode array of FIG. 49;

FIG. 51 is a plan view of a second alternative electrode array of thisinvention;

FIG. 52 is an exploded view of the major component layers of theelectrode array of FIG. 51;

FIG. 53 is a cross sectional view of the components mounted to one ofthe contiguous pairs of tabs of the electrode array of FIG. 51;

FIG. 54 is a plan view of a single carrier of the electrode array ofFIG. 51 while the carrier is still integral with the coupon from whichthe carrier is formed;

FIG. 54A is an enlarged view of the distal end of the carrier of FIG.54;

FIG. 55 is a plan view of a wafer on which plural control modules of theelectrode array are formed;

FIG. 56 is a plan view of a single control module;

FIG. 57 is a side view of a single control module;

FIG. 58 is an exploded view of the plural layers of a substrate of theelectrode array of FIG. 51;

FIG. 59 is a cross sectional view of the substrate of FIG. 58 aftersolder plugs and a solder ring are deposited on the substrate;

FIG. 60 is a perspective view of a superstrate of the electrode array ofFIG. 51;

FIG. 61 is a plan view of the inner surface of the substrate of FIG. 60;

FIG. 62 is a cross sectional view of the substrate of FIG. 60;

FIG. 63 is an exploded view of the layers forming the carrier-laminatesubs-assembly of the electrode array of FIG. 51;

FIG. 64 is a cross-sectional view a section of the carrier-laminatesub-assembly of FIG. 63;

FIG. 65 is a plan view of the distal end of the upper layer ofelectrically insulating material of the carrier-laminate sub-assembly ofFIG. 63;

FIG. 66 is a plan view of the distal end of the middle layer, theconductor layer, of electrically insulating material of thecarrier-laminate sub-assembly of FIG. 63;

FIG. 66A is a cross sectional view of the layers forming the conductorsand capture pads integral with laminate middle layer;

FIG. 67 depicts how plural layers, here plural bottom layers, appear ona sheet of insulating material prior to the separation of the layersfrom the sheet;

FIG. 68 is a cross section through the carrier-laminate sub-assemblyalong a longitudinal axis through one of the carrier tabs;

FIG. 69 is a plan view of the containment ring bonded to the substrate;

FIG. 70 is a plan view of the control module bonded to the substrate;

FIG. 71 is a cross sectional view of the control module bonded to thesubstrate;

FIG. 72 represents the coating of oxide over the substrate;

FIG. 73 depicts the substrate after the upper layer of oxide has beenremoved;

FIG. 74 represents the steps performed to form the lid over the controlmodule and surrounding ring;

FIG. 75 illustrates how the substrate appears after the lid is in place;

FIG. 76 illustrates the positioning of the carrier-laminate sub-assemblyover the substrate and the positioning of the superstrate over thecarrier-lid sub-assembly;

FIG. 77 is a detailed depiction of the opposed substrate and superstratesolder plugs prior to the plugs being bonded together to form aconnecting post; and

FIG. 78 is a cross sectional view of a variation of the secondalternative version of the invention.

DETAILED DESCRIPTION I. Electrode Array Assembly

FIGS. 1, 1A and 2 illustrate an electrode array 40 of this invention.Electrode array 40 includes a number of individual electrodes 42depicted in outline as a number of rectangles in FIGS. 1 and 1A.Associated with each electrode 42 is a control module 44. Each controlmodule 44 is an application specific integrated circuit (ASIC) thatincludes components able to source current from/sink current to theassociated electrode 42. Conductors 46 and 48 extend from the controlmodules 44. Conductors 46 and 48 are connected to a cable 50 thatextends from the proximal end of the electrode array assembly 40. Notillustrated are the individual conductors internal to cable 50. Cable 50is connected to an implantable device controller (IDC) 52. The IDC 52contains the power source for the currents that are flowed between theelectrodes 42. IDC 52 also contains a controller that generates theinstructions that indicate between which electrodes 42 the currents areto be flowed. The specific structure of the IDC 52 is not part of thepresent invention.

Electrode array assembly 40 is shaped to have a base 56 that is the mostproximal portion of the assembly. (Here, “proximal” means towards theend of the assembly at the bottom of FIG. 1; “distal” means towards theend of the assembly at the top of FIG. 1). Three parallel, spaced apartbridges 58, 60 and 62 extend distally forward from base 56. The outertwo bridges, bridges 58 and 62, extend forward from the opposed sides ofbase 56.

Plural tabs 64 extend outwardly from each bridge 58, 60 and 62. Moreparticularly, at a number of spaced apart locations along the length ofeach bridge 58, 60 and 62, two tabs 64 extend outwardly from the opposedsides of the bridge. At least in the version of the invention depictedin FIGS. 1 and 1A, the tabs 64 are arranged in diametrically opposedpairs relative to the bridge 58, 60 or 62, from which the individualtabs extend. Electrode array assembly 40 is further constructed so thatat each longitudinal section on bridge 58 from which tabs extend, tabs64 also extend from the laterally adjacent longitudinal sections ofbridges 60 and 62. Thus, in the illustrated version of the invention,tabs 64 are arranged in rows. In each row of tabs 64, two tabs extendoutwardly from each bridge 58, 60 and 62. The rows of tabs 64 arelongitudinally spaced apart from each other. In some versions of theinvention, the separation between the distal end of one row of tabs andthe proximal end of the distally adjacent row of tabs is between 1 to 10mm. In many versions of the invention, this separation is between 2 and6 mm.

Each tab 64 is generally in the form of a rectangle with roundedcorners. Each tab 64 has a length (measurement along an axis parallel tothe longitudinal axis of assembly 40) of between 0.5 to 5 mm. Often thislength is between 2 and 4 mm. Each tab 64 has a width, (measurementalong the axis perpendicular to the longitudinal axis of assembly 40 inthe plane of FIGS. 2) of 0.25 to 2 mm. In many versions of theinvention, this width is between 0.5 to 1 mm. It should further beunderstood that each tab 64 attached to one bridge 58 or 60 is separatefrom the adjacent tab 64 attached to the adjacent bridge 60 or 62. Thespacing between the adjacent tabs 64 extending from adjacent bridges istypically no more than 500 microns and preferably 100 microns or less.This small separation between adjacent tabs 64 reduces the amount oftissue that can grow between the tabs. If appreciable tissue wereallowed to grow between the tabs 64, this tissue could inhibit laterremoval of the assembly 40.

Beams 66 extend between the bridges 58, 60, and 62. More particularly,each beam 66 extends between adjacent bridges 58 and 60 or betweenadjacent bridges 60 and 62. In the illustrated version of the invention,assembly 40 is further constructed so that each beam 66 connectingbridges 58 and 60 is collinear with an adjacent beam connecting bridges60 and 62. Each beam 66 has a width, (measurement along an axis parallelto the longitudinal axis of the assembly 40) of approximately 0.25 mm.

The electrode array assembly 40 of FIG. 1 is further constructed so thatthere is a pair of collinear beams 66 adjacent the proximal and distalends of each of the tabs 64 in each row of tabs. Thus, in theillustrated version of the invention 16 pairs of beams connected thespaced apart bridges 58, 60, and 62 together.

Given the spacing between the tabs 64, it should be appreciated that thelongitudinally adjacent pairs of beams 66 are spaced apart from eachother along the longitudinal axis of electrode array assembly 40. Asdiscussed below, a flexible membrane 70 is disposed between theseadjacent spaced apart beams 66. In FIG. 1A some membranes 70 are shownby surface shading. Similarly, membranes 72, located on the outer sidesof bridges 58 and 62. Each membrane 72 extends between a pair oflongitudinally adjacent tabs 64 that extend from the outer sides ofbridges 58 and 62. Membranes 70 and 72 are present to inhibit tissuegrowth between the features of the electrode array 40.

Electrode array 40 is also formed to have a head 74 and two shoulders76. Head 74 is located forward center-located bridge 60. Each shoulder76 extends forward from one of the two outer located bridges 58 or 62.Shoulders 76, while connected to head 70 by narrow beams, (beams notidentified) are generally spaced apart from head 74. A more completediscussion of the geometry of the assembly head 74 and shoulders 76 iscontained in the incorporated by reference U.S. Pat. App. No.61/166,366.

An electrode 42 is disposed on each one of the tabs 64. The associatedcontrol module 44 is likewise seated, embedded in, the tab 64.Conductors 46 and 48 extend from each tab to the adjacent bridge 58, 60or 62. If an electrode 42 does not function as a current source or sink,the electrode may function as a voltage probe. When an electrode 42performs this function, the associated conductors 46 and 48 serve as theconductors over which the sensed voltage is connected to a monitoringcircuit (not illustrated and not part of this invention).

By reference to FIG. 2 it can be seen that electrode array assembly 40has a carrier 80 formed from a superelastic material; that is, amaterial that, after being subjected to the strain induced byappreciable rolling, folding or bending, returns to its initial shape.In one version of the invention, the carrier 80 is formed from a nickeltitanium alloy such as Nitinol. Carrier 80 is shaped to form the basicgeometric features of the assembly including base 56, bridges 58, 60 and62, tabs 64, beams 66, head 74 and shoulders 76. Membranes 70 and 72 areformed from material different from which the carrier 80 is formed. InFIG. 2, electrode array assembly is shown active side up. The “active”side is the side of the array 40 on which electrodes 42 are exposed.Opposite the active side, electrode array 40 has a “passive” side, shownas the bottom side in FIG. 2.

Carrier 80 is formed with a number of windows 81, seen best in FIG. 26A.Each window 81 is formed in a separate one of the tab-defining sectionsof carrier 80. Returning to FIG. 2 it can be seen that frames 83 (oneshown) formed from electrically insulating material, are located aroundthe inner surfaces of carrier 80 that define the windows 81. A separatecontrol module 44 is seated in each one of the windows 81 so as to bewithin the frames 83. The side surfaces of each control module 44 areencased in a shell 84 also formed from electrically insulating material.Shell 84 also has a panel that extends over the face of the controlmodule 44 directed to the passive side of assembly 40. Thus, around thesides of the control module 44 both a section of the frame 83 and asection of the shell 84 separate the side surfaces of the control modulefrom the adjacent surfaces of the carrier 80.

Insulating material is disposed on the top, bottom and side surfaces ofthe carrier 80 (side-located insulating material only seen in FIGS. 36and 37). One such insulating material is a conformal coating such as thepolyxylene polymer parylene-C. This insulating material is disposed overthe surfaces of the carrier 80. The insulating material disposed overthe surface of the passive side of carrier 80, the bottom side in FIG.2, is identified as passive side insulating layer 82. In addition tocovering the passive side face of frame 80, passive side insulatinglayer 82 extends over the side edges of the carrier 80.

Three different intermediate layers of insulating material, layers 92,96 and 99 are disposed over the active side of carrier 80. Layers 92, 96and 99 are formed from parylene. Intermediate insulating layer 92 isapplied directly over the active side of carrier 80. Portions of layer92 thus also cover the active side exposed face of control module 44 andthe exposed rectangular carrier faces of the frames 83 and shells 84that surround the modules 44. Conductors 46 are disposed over theintermediate insulating layer 92. A via 94 extends from conductor 46through insulating layer 92 to a bond pad 91 (FIG. 7A) formed on theassociated control module 44. Intermediate insulating layer 96 isdisposed over insulating layer 92 and conductor 46. Conductors 48 aredisposed over intermediate insulating layer 96. A via 98 extends fromeach a bond pad 91 integral with each control module 44 to the conductor48 associated with that control module 44. In FIG. 2, the individuallayers of metal forming conductors 46 and 48 are shown. These layers aredescribed and called out in the illustrated in the sequence of drawingsthat describe the assembly of electrode array 40 of this invention.

Intermediate insulating layer 99 is the outermost of the threeintermediate insulating layers 99. Intermediate insulating layer 99extends over intermediate insulating layer 96 and conductors 48.

Electrodes 42 are disposed over the intermediate insulating layer 99.Each electrode 42 includes a base pad 101 that is disposed on the outersurface of the intermediate insulating layer 99. Each electrode base pad101 includes a layer of titanium 102 that is contact with theintermediate insulating layer 99. A layer of gold 103 is disposed overtitanium layer 102. A layer of titanium 104 is disposed over the exposedsurface of gold layer 103. A via 106, formed of gold, extends from goldlayer 103 to a bond pad 91 integral with the associated control module44. Each via 106 thus extends through the intermediate insulating layers92, 96 and 99. Spaced apart conductive buttons 107 are disposed over theouter surface of titanium layer 104. Each conductive button 107 includesa titanium layer 108 that is disposed on the base pad titanium layer104. A thin layer of iridium or iridium oxide 109 is disposed over eachtitanium layer to complete the conductive button. The exposed faces ofthe iridium layers 109 of the conductive buttons are the conductivesurfaces of each electrode that contact the tissue to which theelectrode is applied.

An outer insulating layer, layer 110, is disposed over intermediateinsulating layer 99. Outer insulating layer 110 is formed from the samematerial from which insulating layers 82, 92, 96 and 99 are formed.Outer insulating layer 110 is also disposed over portions of theelectrodes 42. More particularly, portions of insulating layer 110 aredisposed over the sections of the electrode titanium layer 104 locatedbetween the conductive buttons 107. Small sections of insulating layer110 also surround the outer perimeters of the exposed iridium faces ofthe buttons 107. Openings 112 in outer insulating layer 110 function asaccess holes through which the tissue can pass across insulating layer110 and contact the conductive buttons 107 integral with the electrodes42.

Often electrode array 40 of this invention will have a thickness, thedistance from the exposed face of passive side insulating layer 82 tothe exposed face of outer insulating layer 110 of no more than 200microns. In many cases this thickness is 150 microns or less and instill more preferred versions of the invention, this thickness is 100microns or less. The side-to-side width across the array 40 is afunction of the number of columns of electrodes 42. In the illustratedversion of the invention, where there are 6 columns of electrodes 42,the width is typically 15 mm or less and often 10 mm or less. Similarly,the length of the array 40 is a function of the number of rows ofelectrodes 42. In the version of the invention illustrated in FIG. 1wherein there are 9 rows of electrodes 42, the top-to-bottom length ofthe array is 100 mm or less and can be 70 mm or less. In FIG. 2 and thesubsequent Figures, the layers of material forming the components ofelectrode array 40 are not shown to scale unless otherwise stated. Thisis to facilitate illustration of the components of this invention.

As seen in FIG. 3, in at least some versions of the invention, each pairof conductors 46 and 48 forms a set of the lowest order branches from atwo-wire bus 118. In FIG. 3, the two conductors forming bus 118 areshown as each having three first order branches, only one of which iscompletely illustrated. This reflects that each one of the first orderbranches extends over a separate one of the array bridges 58, 60 and 62.The control modules 42 associated with each bridge 58, 60 or 62 are tiedto the branch of the bus that extends over the bridge. In FIG. 3 onlysix pairs of control modules are shown tied to the illustrated branch ofbus 118. This is for ease of illustration only.

The exact structure of the control module 42 is not part of thisinvention and is not illustrated. For purposes of understanding theelectrode array 40 of this invention, it should be understood that eachcontrol module 42 includes a node controller. One function of the nodecontroller is to provide the physical connection between conductors 46and 48, and therefore bus 118, and the other components internal to themodule. A second function of the node controller is to, based oninstructions received over the bus 118 and conductors 46 and 48,selectively actuate the other circuits internal to the control module42. A power supply circuit harvests and stores the energy contained inthe signals transmitted over the bus. The power supply circuit alsostores the energy and uses the stored energy to power the othersub-circuits internal to the module 44. Control module 44 also containsa current source and a current sink, both of which are selectively tiedto the electrode 42. Control module 44 also includes an analog todigital converter that is also tied to the electrode 42.

FIG. 4 represents the command packet 120 that may be transmitted overthe bus 118 to the electrodes 42. One component of the packet 120 is anaddress field 121 (E ADRS). Address field 121 identifies the individualcontrol module 44 for which the command contained in the packet 120 isintended. An opcode (OPCODE) field 122, also a component of the commandpacket 120. The opcode field 122 is the specific instruction that is tobe taken by the control module 44. Examples of such instructionsinclude: activate current source; activate current sink; and activeanalog to digital converter so a reading of the voltage present at theelectrode may be obtained. Some command packets 120 also include anoperand (OPAND) field 123. The operand field 123 contains dataindicating the value associated with the operand. An example of a valuecontained with an operand is the level of the current draw to which thecurrent sink should be set when activated.

The protocol by which signals are transmitted over bus 118 to and fromthe control modules 44 is not part of the present invention.

In FIGS. 1 and 1A the conductors forming bus 118 appear as linesextending over the array base 56 and bridges 58, 60 and 62. This is forpurposes of illustration only. In actually, the bus conductors, likeconductors 46 and 48, are covered by insulating layers and are notvisible. Also, not illustrated in the Figures are the connectionsbetween the on-carrier conductors forming bus 118 and the individualconductors internal to cable 50. This bonding may be achieved bymicro-ball bonding.

An electrode array 40 of this invention can be constructed to have 10 ormore and even 20 or more electrodes 42 each of which can be individuallycontrolled. An advantage of the array 40 having this number ofelectrodes is that it allows the practitioner to precisely targetthrough which tissue the current is flowed. This allows thepractitioner, often through experimentation, target the current flowthrough the patient so that the current flow offers an appropriatebalance between beneficial effects and tolerable side effects. Even whenhaving this relatively large number of electrodes, the power andcommands supplied to the electrodes be supplied over an implanted cable50 with just two conductors. This minimization of the number ofconductors in cable 50 makes it possible to implant the conductors usingminimally invasive surgical techniques.

Furthermore, it is anticipated that in many versions of the invention,each control module 44 will function as the current source and sink tono more than eight individual electrodes 42 and more preferably no morethan four individual electrodes 42. In the above described version ofthe invention, each electrode 42 has its own dedicated control module44. Accordingly, the power source/sink signals generated by each controlmodule typically has to travel a distance of no more than 10 cm usually,often 3 cm or less and more preferably 0.5 cm or less. An advantage ofthis construction of the invention is that the power required toprecisely source/sink currents over these relatively small distances isless the power required to source/sink currents from a device externalto the array. Consequently, a portable power source built into the IDC52 can provide power for a longer time than if the source was requiredto provide power to individual electrodes spaced 15 cm or more from theIDC 52.

The thin passive side-to-active side profile of array 40 and that thecarrier 80 is formed from material that if, not superelastic is at leastflexible both facilitate the implantation of the array using minimallyinvasive medical techniques. For example, prior to implantation thearray could be rolled or folded into a cannula having a lumen with adiameter less than the unrolled/unfolded width of the array. The cannulais directed to the target location in the body at which the array is tobe deployed. The array is inserted into the body through the cannula.Once the array is discharged from the cannula, the array isunrolled/unfolded over the tissue through which the current is to beflowed.

The parylene forming the layers 92, 96 and 99 through which the vias 94,98 and 106 extend are flexible. This reduces the mechanical stress towhich the vias themselves are exposed. Each via 94, 98 and 106 has amaximum diameter of 80 microns and typically 50 microns in diameter orless. This means that the vias themselves are not so large in crosssectional size that they are not able to themselves flex. The viasthemselves are connected directly to the bond pads 91 integral with thecontrol module 44. The need to provide very thin, and therefore veryfragile, wire bonds to the control module is eliminated. Further themaximum height of the vias, is typically 100 microns or less and often50 microns or less. In the version of the array illustrated in FIG. 2,vias 106 are the tallest vias. As a consequence of the vias 95, 98 and106 being of relatively short height, they are not exposed to largemechanical stresses. Likewise, conductors 46 and 48 and the conductorsforming bus 118 have heights that are typically less than 5 microns andoften 3 microns or less. The widths across these conductors are usually75 microns or less and may be 40 microns or less. These design featuresfacilitate the flexibility of these conductors. Collectively, thesedesign features of the electrode array 40 of this invention reduce thelikelihood that the mechanical vibrations and shocks to which the arrayis invariably subjected will so stress these electrical connections thatthe connections break.

While the parylene layers 92, 96 and 99 the underlying assemblysubstrate, carrier 80, are flexible, the carrier is less flexible thanthe parylene layers. The reduced flexibility, increased rigidity, of thecarrier is what causes the electrode array assembly 40 to conform to thesurface of the tissue against which the assembly is deployed. Thisfeature of the assembly 40 is what holds the assembly electrodes 42against the tissue to which the therapeutic current is to be applied.

Likewise, even though the array 40 may have 20 or more electrodes 42 itcan be possible to provide cable 50 with often four or less and oftenjust two individual conductors over which current is sourced to andinstructions are provided to all of the electrodes. This means theseconductors, which are not attached to a substrate, may themselves berelatively thick, for example 50 micron or more in diameter andsometimes 100 microns or more in diameter. This facilitates theformation of conductor-to-array bonds with these conductors that areless fragile than the bonds used to hold thinner conductors to thearray. This reduction in bond fragility means that it is less likelythat, over time, owing to the inevitable mechanical shock to which thearray is exposed, one of the bonds will break.

II. First Method of Assembly

One method of assembling electrode array 40 of this invention is nowexplained by initial reference to FIG. 5. Initially, a layer of photoresist 129 is disposed over a substrate, here a silicon wafer 128. (Stepnot illustrated.) Openings 130 (one shown) are formed in the photoresist 129 at the locations where the control modules 44 are to beseated in the silicon wafer 128. Once openings 130 are formed in thephoto resist layer 129, using a reactive ion etching process, openings132 (one shown) are formed in the silicon wafer 128. The openings 132 isformed so that the portions of the wafer 128 that define the openingsare located inwardly of the portions of the photo resist 129 that definethe perimeter of photo resist openings 132.

As represented by FIG. 6, with photo resist layer 129 still in place,boron is diffused into exposed sections of the silicon wafer 128 thatare located inwardly of photo resist openings 130. The boron is diffusedapproximately 25 microns into the silicon wafer 128. This boron thusdiffuses into the portions of the silicon wafer that define the sidewalls around the bases of wafer openings 132. The boron diffusedsections of silicon become the shells 84 (one shown) of assembly 40 andare therefore identified out as such in the Figures. Photo resist layer129 is then removed from the silicon wafer 128, (step not shown).

As a consequence of the formation of shells 84, each shell 84 has anexposed face 85, seen in FIG. 7, that is generally in the shape of arectangular frame. Using a reactive ion etching process, small bores 134are formed in the exposed faces of the shells 84. Bores 134 have adiameter of approximately 0.2 to 1 micron and extend no greater than 10microns deep into the shell 84. To minimize the complexity of the laterFigures, bores 134 are only illustrated in FIGS. 7 and 7A. It should beappreciated that, in this etching process, as well as in a number ofprocesses in the assembly of electrode array 40, include the sub-stepsof applying a photo resist layer, selectively removing portions of thephoto resist layer and removing the photo resist layer. Many of theseindividual sub-steps, as they apply to the formation of bores 134 andother below described processes are neither described nor illustrated.

A control module 44 is then seated in each silicon wafer opening 130 asrepresented by FIG. 8. The control module 44 is disposed in the shell 44so that the face of the module on which the bond pads 91 are formedfaces outwardly. Control module 44 has a top-to-bottom height that istypically 2 microns or less then the depth of the wafer opening.Accordingly, as represented by FIG. 9, the next step in the assembly ofthe electrode-control module-conductor sub-assembly is the removal ofthe upper sections of the silicon wafer 128 and shells 84 that extendabove control modules 44. This removal process is performed bymechanical lapping, removing the outer layers of both the wafer and theshells. As part of the lapping process, the exposed the die, shell andwafer are cleaned. This cleaning step is the only inter-step cleaningstep described. Neither this cleaning step nor any of the other cleaningsteps are illustrated. This cleaning is performed in part to removedebris from shell bores 134. Uniformity of the levels of the die, thewafer and shell are then checked, step not illustrated.

Small closed end bore holes 136, seen in FIG. 7A, are then formed in theexposed face of the die forming control module 44. Bores 136 have adiameter of between 1 and 2 microns and a depth of no more than 10microns. Holes 136 are formed by a reactive ion etching process. Tominimize the complexity of the drawings, bores 136 are only illustratedin FIG. 7A.

A first insulating layer, intermediate insulating layer 92, is thenapplied over the coplanar surfaces of the control modules 44, shells 84and silicon wafer 128, as represented by FIG. 10. Intermediateinsulating layer 92 has a thickness of no greater than 20 microns.Parylene is a conformal coating. During the vapor deposition process inwhich the parylene of intermediate insulating layer 92 is applied, afraction of the parylene flows into the shell bore 134 and die bores136. The parylene in bores 134 and 136 holds the parylene forminginsulating layer 92 to the surfaces of the dies 44, shells 84 and wafer128.

During the process of forming intermediate insulating layer 92, theparylene is applied to cover a surface area larger than that subtendedby the individual electrodes. The parylene is applied to cover a surfacearea that typically is greater than the surface area of the electrodearray 40. In the subsequent described steps in which insulating layers82, 96, 99 and 110 are formed, the parylene is similarly applied tocover the same surface area as the parylene forming insulating layer 92.The reason for this relatively wide surface application of the paryleneis discussed below.

FIG. 11 illustrates that holes 138 (one shown) are formed inintermediate insulating layer 92. Each hole 138 is in registration overthe control module bond pad 91 to which the associated conductor 46 isconnected. Holes 138 are formed by, first, applying a photo resist layerover insulating layer 92. Openings are formed in the photo resist layerwhere the holes 138 are located. An oxygen plasma etching process isused to form the holes 138. Holes 138 have a diameter equal to that ofthe vias 94 (FIG. 2) that will subsequently be formed in the holes. Thephoto resist layer is then removed.

Once holes 138 are formed, a layer of titanium 140 is vapor depositedover intermediate insulating layer 92 as represented by FIG. 12.Titanium layer 140 has a thickness of no greater than 5000 Angstroms.The titanium of layer 140 functions as an adhesion layer for the nextapplied layer 142. Gold is then vapor deposited over titanium layer 140as seen by FIG. 12 so as to form layer 142. The gold of layer 142 has athickness of no greater than 5000 Angstroms. The gold of layer 142functions as a seed layer for the next layer of gold that is ofsubstantially greater thickness.

In FIGS. 12 and 13, the titanium of layer 140 and the gold of layer 142are shown as extending over the hole 138. This is for ease ofillustration. In actuality very small amounts of the titanium and goldthat, respectively, form layers 140 and 142 flow into the hole 138. Thesame is true for the titanium adhesion layers and gold seed layersdisposed over holes 154 (FIG. 17) and holes 165 (FIG. 20).

It should be understood that titanium layer 140 and gold layer 142 aredeposited over substantially the whole of intermediate insulating layer92. Fabrication of conductors 46 and the associated conductor of bus 118continues with the application of a photo resist layer 143 over goldlayer 142. Openings are formed in the photo resist layer 143 to exposethe sections of the gold layer 142 over which the conductors 46 are tobe formed. Gold is applied by an electroplating process over the exposedsurfaces of gold layer 142. In FIG. 14 and the subsequent Figures thegold applied over the assembly from these two process form a singlelayer, called out to the right of the control module 44 in FIG. 14 aslayer 148. Layer 148 has a thickness of approximately 2 microns.

As a consequence of the application of the gold forming layer 148 aportion of the gold flows into the openings 138 formed in insulatinglayer 92. This gold bonds with the underlying control module contactpads 91 so as to form the vias 94 that extend to conductors 46.

Titanium adhesion layer, layer 150 in the Figures, is then applied by avapor deposition process over the exposed surface of gold layer 148.Titanium adhesion layer 150 typically has a thickness no greater than5000 Angstroms. While not illustrated, some of the titanium deposited inthis process covers the exposed surface of photo resist layer 143.extend over

Photo resist layer 143 is then removed, step not shown. As shown in FIG.14, photo resist layer 143 extends above titanium adhesion layer 150.Consequently, the photo resist layer 143 can be removed by a chemicallift off process. As a consequence of this process, the titaniumdeposited on top of the photo resist layer 143 is also transported awayfrom the electrode-control module-conductor assembly. The removal ofphoto resist layer 143 exposes the portions of the titanium layer 140and gold seed layer 142 that do not form part of the conductors 46.

Masks are then deposited over the conductor 46 and the conductor of bus118, step not shown. A gold-specific chemical etch process is employedto remove the exposed gold seed layer 142. A titanium-specific chemicaletch process is then employed to remove the sections of the titaniumlayer 140 previously covered by the gold seed layer 142. The masks arethen removed. As a consequence of the removal of layer 140 and 142, asseen in FIG. 15, what is left on the intermediate insulating layer 92are sections of laminate that comprise a titanium layer 140 a gold layer148 and a titanium layer 150. These laminate structures are theconductors 46. Other ones of the laminate structures form the conductorsof bus 118.

In FIG. 15 and the subsequent Figures the gold layer 148 of conductor 46as well as the gold layer 162 of conductor 48 (FIG. 18) and the goldlayer 103 of the electrode 42 (FIG. 23) are shown as being of the samethickness as the adjacent titanium layers. This is for ease ofillustration only. As indicated by the above stated dimensions, thesegold layers are typically at least 4 times larger in thickness than theadjacent titanium layers.

Once conductors 46 and the associated bus conductor are formed, paryleneis applied over the conductor 46 as well as intermediate insulatinglayer 92 to, as illustrated by FIG. 16, forming intermediate insulatinglayer 96. In regions where the parylene forming insulating layer 96 isapplied directly over insulating layer 92, layer 96 has a thickness istypically 10 microns or less. In FIGS. 2 and 16 and in the followingFigures, the portion of insulating layer 96 disposed over conductor 46appears to have a lesser thickness than the portion of layer 96 disposeddirectly onto layer 92. This is for ease of illustration only. Inactuality, the thickness of insulating layer 96 is generally uniformover the different components of the assembly on which the paryleneforming the layer is applied. In some versions of the invention layer 96has a thickness of approximately 10 microns. As seen in FIG. 17, holes154 (one shown) are formed in intermediate insulating layer 96. Eachhole 154 is centered over the die bond pad 91 to which a via 98 extends.Each hole 154 thus extends through both the intermediate insulatinglayer 96 and the underlying intermediate insulating layer 92. Each hole154 has the diameter of the via 98 (FIG. 2) that will be subsequentlyformed in the hole 154.

FIGS. 17, 18 and 19 represent that conductors 48 are formed in the samegeneral manner in which conductors 46 are formed. Layers of titanium andgold, respectively layers 156 and 158, are disposed over intermediateinsulating layer 96. Not illustrated are small amounts of titanium andgold that form layers 156 and 158 that flow into holes 154. A mask 159is applied over the surfaces of gold layer 158 that are not to be partof the conductors 48 and associated bus 118 conductor. Gold iselectroplated over the sections of gold layer 158 that are open throughthe mask 159. In FIG. 18 the relatively thick layer of gold formed bythis layer and the underlying gold layer 158 is called out as layer 162.A titanium layer 164 is applied on top of gold layer 162. Titanium andgold layers 156, 162 and 164 have the same thicknesses as, respectively,layers 140, 148 and 150.

As a consequence of this electroplating process, gold flows into holes154 that extend through insulating layers 92 and 96. This gold bonds tothe underlying control module contact pad 91 and forms via 96.

Mask 159 is then removed. The sections of first gold layer 158 and thentitanium layer 156 previously covered by mask 159 are then removed.These removal processes are the same employed with respect to theremoval of layer 140 and 142. As a result of the removal of thesesections of layers 156 and 158. The electrode-control module-conductorassembly is left with the conductors 48 and associated bus 118conductor. In FIG. 19 a single conductor 48, consisting of a laminate oflayers 156, 162 and 164 is shown. Again, in FIG. 19 and the otherFigures, the relative thickness of these layers is not shown.

The sub-assembly is then prepared for the fabrication of the electrodes42. As depicted in FIG. 20, this process begins with the application ofparylene to establish the outermost intermediate insulating layer, layer99. Intermediate insulating layer 99 is thus disposed over theconductors 48, the associated bus conductor and the exposed surfaces ofintermediate insulating layer 96. Where insulating layer 99 is disposedover insulating layer 96, layer 99 typically has thickness of 10 micronsor less. While not apparent in the Figures, insulating layer, thethickness of insulating layer 99 is generally constant regardless of theassembly component over which the parylene forming the layer is applied.Once intermediate insulating layer 99 is formed, holes 165 (one shown)are formed in this layer, as well as underlying insulating layers 96 and92. Each hole 165 is centered over the die bond pad 91 to which theassociated electrode 42 is connected. Each hole 165 has the diameter ofthe via 106 that is to be subsequently formed in the hole.

Once intermediate insulating layer 99 is applied to the sub-assembly,titanium and gold seed layers are applied to the assembly by separatevapor deposition processes to facilitate the fabrication of theelectrode base pad. FIG. 21 illustrates that these layers, a titaniumlayer 166 and a gold layer 168 are applied over the whole of insulatinglayer 99. While not illustrated, a small fraction of the titanium andgold vapor released in this process flows into the holes 165.

Once titanium layer 166 and gold layer 168 are applied, process stepsare performed to increase the thickness of the gold layer and form atitanium adhesion layer adhesion layer on top of the gold layer. Theseprocess steps are the same as the process steps used to complete theformation of the conductors 46 and 48 and the conductors integral withbus 118. Accordingly, these steps are neither described nor illustrated.At the conclusion of this process, as seen in FIG. 22, the base pads 101(one shown) of the electrodes 42 are formed as illustrated in FIG. 22.Titanium layer 102 has a thickness of typically less than 5000Angstroms. Gold layer 103 has a thickness of approximately 20 microns.Titanium layer 104 has a thickness of typically less than 5000Angstroms. Gold layer 103 is thicker than gold layers 148 and 164 is toincrease the radio-opacity of the electrode array assembly 40 in thevicinity of the electrodes 42.

As part of the electroplating process in which the gold that forms thelargest portion of layer 103 is applied, some of the gold flows intoholes 165. This gold bonds to the underlying control module contact pad91 so as to form the control module-to-electrode via 106.

Conductive buttons 107 are then formed over the electrode base pads asseen by reference to FIG. 23. This process begins by the formation of amask over the exposed titanium layer 104 (step not shown). This mask isformed so as to define openings in the sections of the electrode basepad titanium layers 104 over which the buttons 107 are to be formed.Once the mask is formed, titanium is sputtered over the assembly to formthe individual titanium layers 108. Each titanium layer 108 typicallyhas a thickness of less than 5000 Angstroms. Iridium or iridium oxide isthen sputtered over the assembly to form button layers 109. Iridiumlayers 109 often have a thickness of less 30,000 Angstroms and moreoften less than 10,000 Angstroms. The buttons 107 formed in this processare typically rectangular cross sectional profile. Often the longestlength along one of the side edges of a button is 125 microns or less.In some versions of the invention, the longest length along one of theseedges is 60 microns or less. The photo resist mask is then removed.

Once the buttons are formed over the electrodes, outer insulating layer110, is formed over the electrodes. Insulating layer 110, likeinsulating layers 82, 92, 96 and 99, is a parylene coating. Initially,the parylene forming layer 110 is applied to the whole of the assemblyto cover the exposed surfaces of insulating layer 99 as well as theelectrodes 42, including the buttons. The parylene forming the portionsof insulting layer 110 that extend over insulating layer 99 generallyhas a thickness of 10 microns or less. While not apparent in thedrawings, this thickness is relatively constant, even for the sectionsof layer 110 disposed over the electrodes 42. Portions of this paryleneare selectively removed to forming openings 112 as seen in FIG. 24. Inthis process, the openings 112 are formed so as to have cross sectionalareas that are slightly less than that of the underlying buttons. Inother words, the parylene forming outer insulating layer 110 extendsaround the outer perimeters of the electrode buttons 107. Generally,each opening 112 is formed so as to expose at least 50% of the face ofthe underlying button 107.

Fabrication of the sub-assembly consisting of the electrodes 42, thecontrol modules 44, conductors 46 and 48 and multiple insulating layersconcludes with the separation of the sub-assembly from silicon wafer128. In one method of this invention, this process is performed by TMAHso as to etch away the silicon forming wafer 128. As seen by referenceto FIG. 25, this leaves encased control modules 44 suspended below thelaminate structure consisting of the conductors, the insulating layersand the electrodes. This laminate structure can be considered a laminatesheet of insulating material. The control modules 44 are suspended fromone side of the sheet, the electrodes 42 are disposed an opposed side ofthe sheet and the conductors and vias extend through the sheet.

In FIG. 25, only a single electrode 42, a single control module 44 asingle pair of conductors 46 and 48 is shown connected to the layers ofinsulating material. It should be understood that this assembly includesthe plural electrodes 42, control modules, conductors 46 and 48 and bus118 of the electrode array 40.

As part of the presently described method of assembly of this invention,the carrier 80 is prepared to receive the electrode-controlmodule-conductor assembly. This process begins with the basic formationof the carrier which is now described by initial reference to FIGS. 26and 26A. In the initial steps of the carrier-formation process, asection of a coupon 182 is shaped to define the carrier 80. The coupon182 is a sheet of the carrier-forming material. In one version of theinvention coupon 182 is a sheet of Nitinol that has a thickness of 50microns. In this process, portions of the coupon 182 are selectivelyremoved to define a set of slots 184 in the coupon that essentiallydefine the whole of the outer perimeter of the carrier 80. Slots 186 andopenings 198 are also formed in the coupon so as to define the featuresof the carrier 80. These features include bridges 188, 190 and 192, thatcorrespond to assembly bridges 58, 60 and 62, respectively. Otherfeatures formed in this step are tabs 194 and beams 196 that correspondto assembly tabs 64 and beams 66, respectively. In the Figures, openings198 are the openings between the adjacent carrier beams 196 thatseparate the adjacent rows of carrier tabs 194.

Another internal carrier feature formed in this processes are thewindows 81 that extend through the carrier-forming section of the coupon182. Each window 81 is formed so as to be in a location in the carrier80 in which one of the control modules 44 is mounted. In the illustratedversion of the invention, a window 81 is formed in each one of thecarrier tabs 194. For reasons apparent below, each window 81 subtends anarea that is slightly greater than the area of the occupied by thecontrol module 44 that is to be seated in the window. In one version ofthe invention, each window 81 is formed so as to allow a separation ofapproximately 25 microns between the outer surface of the control moduleshell 84 and the adjacent inner surface of the coupon/carrier sectionthat defines the window. This separation extends around the whole of theperimeter of the shell 84.

In versions of the invention wherein the carrier 80 is formed fromNitinol, these carrier defined features are formed by selectivelyetching away section of a Nitinol coupon 182. This process is performedby chemical etching.

As mentioned above in the above process, the slots 184 that are formedin the coupon 182 to define the carrier 80 are not formed to completelydefine the carrier, and therefore completely separate the carrier fromthe surrounding portion of the coupon. Instead, the coupon 182 is shapedso that small tabs 204 separate the slots 184 so as to connect thecarrier-forming section of the coupon with the rest of the coupon 182.In the illustrated version of the invention, two tabs 204 connect thecarrier forming section of the coupon with the surrounding section ofthe coupon. The tabs 204 are located at the opposed longitudinally endsof the carrier forming section of the coupon 182.

In some versions of the invention, the coupon is prepared for thesubsequent manufacturing steps by forming the tabs 204 so that the tabs204 have a thickness that is less than the thickness of the rest of thecoupon 182. This process may be performed by an etching process on thesections of the coupon in which the tabs 204 are to be formed so as toonly partially remove the material form the forming the coupon 182. Insome versions of this invention, this process of partially etchingsections of the coupon 182 to form the tabs 204 is performed prior tothe step of etching other sections of the coupon to form the carrierdefining slots 184 and 186 and openings 198.

While not illustrated, after the carrier 80 is formed on the coupon 182the carrier may be shaped to develop a shape that is non-planar withrespect to the surrounding sections of the coupon 182. For example thecarrier of FIGS. 26 and 26A may be bent so as to have arcuate curvaturethat is perpendicular to the longitudinal axis of the carrier 80. If thecarrier 80 is so bent, the lateral side edges of the carrier would thusbe above or below the plane of the page on which the carrier of FIG. 26is presented.

The method of shaping the carrier 80 is a function of the material fromwhich the carrier/coupon is formed. For example, if the carrier/couponis formed from Nitinol, this shaping may be performed by placing thecoupon in a mold in which the carrier is bent appropriately whilesimultaneously heating the coupon. Under heat, the carrier-definingsection of the coupon would develop the desired shape.

FIG. 27 illustrates a longitudinal section through a portion thecarrier-defining section of the coupon. Shown in FIG. 27 and subsequentFIGS. 28 and 31-33 is a longitudinal slice through one of the carriertabs 194, the beams 196 on either side of the tab and a window 81 in thetab.

Once the coupon 182 is formed to define the carrier 80, parylene iscoated to the surfaces of the coupon, including the surfaces of thecarrier. In FIG. 28 the parylene is shown on the top and bottom faces ofthe tab 194 and the surfaces of the tab 194 that define window 81.Parylene is also shown on the opposed top and bottom surfaces of thebeams 196 and the side surface of the beams 196 directed away from theadjacent tab 194. This parylene is called out as layer 203. Parylene isnot shown on the opposed adjacent surfaces of the tab 194 and beams 196that define the slots 186 between the tab and beams. This omission isfor only for ease of illustration. Parylene covers these opposedsurfaces. These parylene coatings do not close the gaps between thecarrier tabs 194 and bridges 196. As part of this coating process, theparylene is also coated on the sections of the coupon on that do notdefine the carrier 80.

The parylene-coated coupon 182 is then bonded to a rigid substrate 206now described with respect to FIG. 29. In one version of the invention,substrate 206 is a silicon wafer. Prior to the carrier bonding process,a layer of silicon dioxide 208 is formed on the outer surface ofsubstrate 206. Silicon dioxide layer 208 serves as a sacrificial releaselayer. A coating of parylene 210, seen in FIG. 30, is applied to theouter surface of the silicon dioxide layer 208.

FIG. 31 illustrates the bonding of the coupon 182 to the substrate 206.More particularly, in this step, the parylene layer 203 on one the facesof the coupon 182 is bonded to the parylene 210 disposed over thesilicon dioxide layer 208. These two parylene layers merge into a singlelayer that becomes the passive side insulating layer 82 of the electrodearray assembly 40. Accordingly, in FIGS. 31-36 this layer is identifiedas the passive side insulating layer 82.

As described above, some assemblies of this invention may have a carrier80 that has a non-planar shape. In these versions of the invention, asconsequence of the bonding of the carrier-defining coupon 182 to thesubstrate 206, the carrier 80 is temporarily flexed back into the shapeit which the carrier is coplanar with the rest of the coupon 182.

Once the carrier-containing coupon 182 is bonded to the substrate 206,the parylene around the perimeters of the carrier windows 81 is removed,step not shown. The removal of this parylene is performed by reactiveion etching. Once the parylene is removed from around the carrierwindows 81, the frame 83 is formed around the surfaces of the carrierthat define the windows 81 as seen in FIG. 32 In one version of theinvention, the frame 83 is formed by applying a layer of silicon dioxideto the window-defining surfaces using an oxidative deposition process.Alternatively, frame 83 is formed from a polydimethyal silioxanesilicon. This type of frame 83 may be applied using an adhesive bondingprocess.

Assembly of electrode array assembly 40 continues with the seating andmating of the electrode-control module-conductor assembly to the coupon182 as represented by FIG. 33. In this process step, the sub-assemblyincluding the electrodes, the control modules and the conductors isdisposed over the carrier-containing coupon 182 so that theshell-encased control modules 44 seat in the carrier windows 81. In thismating process, the parylene of intermediate insulating layer 92 (FIG.8) of the electrode-control module-conductor assembly is bonded to theexposed parylene layer 203 of the carrier-containing coupon. Thisparylene-to-parylene bond is what holds the electrode-controlmodule-conductor sub-assembly to the carrier 80. The two parylene layers92 and 203 become a single parylene layer. Accordingly, in FIGS. 33-37,these layers are identified as the bottom most intermediate insulatinglayer, layer 92.

In FIG. 33, insulating layers 82, 92, 96, 99 and 110 are shown asextending across the openings 198 that separates the carrier tab 194from the adjacent beams 196. As discussed above the parylene formingthese layer 82, 92, 96, 99 and 110 is applied so as to extend over asurface area that is larger than that of the electrode array 40 underfabrication. Consequently, as seen in FIG. 33, the insulating layersformed by the parylene extend beyond the perimeter of the carrier tabs104. These insulating layers extend across the gaps between the carriertabs 194 and the adjacent carrier beams 196. These insulating layersalso extend over the carrier windows 198 between the beams 194. Owing tothe flexible nature of the parylene, within the carrier openings 198 theparylene forming the passive side insulating layer 82 bonds with theparylene forming the bottommost intermediate insulating layer 92. Thisparylene-to-parylene bonding is performed under at least a partialvacuum. Consequently, as a result of this process the parylene of layers92, 96, 99 and 110 collapse over the side edges of the carrier 80. Theparylene of layer 92 bonds to the parylene of layer 82. Thus, eachmembrane 70 is formed by the laminate structure of the insulating layers82, 92, 96, 99 and 110. Similarly, adjacent the outer edges of thecarrier bridges 188 and 192, the parylene layers extends between thelongitudinally adjacent carrier tabs 194. In this area between thecarrier tabs 194 the parylene forming insulating layers 82 and 92 againbond. Each membrane 72 thus similarly consists of a laminate comprisinginsulating layers 82, 92, 96, 99 and 110.

Electrode array assembly 40 is now removed from substrate 206. Thisprocess begins with the removal of the parylene layers 82, 92, 96, 99and 110 that extend over carrier slots 184 and 186. The removal of theparylene above and below the carrier slots 186 allows array tabs 64 andbeams 66 to flex relative to each other. A reactive ion etch process, anoxygen plasma etch process, can be used to remove these sections ofparylene. As a consequence of this etching process, as seen in FIG. 34,tabs 204 are exposed.

The electrode array assembly removal process continues with the severingof the carrier from the surrounding section of the coupon 182. Typicallythis process involves the removal of tabs 204. In versions of theinvention wherein the carrier-defining coupon 182 is formed fromNitinol, tabs 204 are removed by using a mixture of HF₃ and HNO₃ to etchaway the Nitinol forming the tabs. As a consequence of this process, asmall remainder section of each tab, identified as crest 212 in FIG. 35projects outwardly from perimeter of the carrier 80 (one crest shown). Acrest also extends outwardly from the surrounding coupon 182. Since thatcrest is not relevant to this invention, it is not illustrated. Anotherreactive ion etching process may then be performed to remove theparylene of insulating layer 82 that was previously covered by the tabs.

Once the tabs 204 are removed, a layer of parylene is deposited over theassembly. This layer is approximately 1 micron thick. In FIG. 36, thislayer is only illustrated as layer 216 disposed over the sides of the ofthe carrier 80. Thus, this parylene layer 216 covers the exposed sideedges of the frame 80 including the crests 212. While not illustrated,it should be understood that parylene layer 216 also extend over theexposed face parylene layer 110. Once layer 216 is applied, a reactiveion etching process may be used to remove portions of the paryleneforming layer 216 so as ensure openings 112 remain open.

The silicon dioxide layer 208 between substrate 206 and the passive sideinsulating layer is removed. This process may be performed by etchingaway the silicon dioxide layer 208 using a chemical etch process. Asseen by reference to FIG. 37 as a consequence of this etching processthe section of the silicon dioxide material disposed under the sectionsof the coupon 182 that do not function as the carrier are also removed.

Once the silicon dioxide layer is removed from underneath the electrodearray assembly 40, the electrode array 40 is no longer connected toeither the coupon 182 or the substrate 206. The array 40 is lifted awayfrom the coupon and substrate 206 for any further processing and testingthat is not part of this invention.

III. Alternative Method of Assembly

An alternative method of assembling the electrode array assembly 40 a(FIG. 49) of this invention can start with the formation of thecoupon-defining carrier 182 previously described with reference to FIGS.26, 26A and 27. In this version of the invention, the coupon 182 mayhave a thickness that is typically no more than 5 microns greater thanthe thickness of the control module 44. Once the coupon 182 is properlyshaped, the carrier-forming section of the coupon may be itself shapedso this section of the carrier acquires the desired non-planar shape ofthe end assembly 40. The surface of the carrier 182 opposite the surfaceon which the electrodes 42 are to be disposed is then coated withparylene, step not illustrated. During the application of this parylenelayer, the parylene is applied so as to coat the side surfaces of thecarrier 80

The coupon-defining carrier 182 is then bonded to the rigid substrate206. As previously described with respect to FIGS. 29 and 30, substrate206 is prepared for this bonding process by first applying silicondioxide layer 208 over the substrate 206. Then, parylene layer 210 iscoated over silicon dioxide layer 208.

FIG. 38 represents the bonding of the carrier-defining coupon 182 to therigid substrate 206. If the carrier 80 was, in the early step, shaped,as a consequence of this process, the carrier-forming section of thecoupon 182 is flexed back into the plane of the coupon 182. In FIG. 38and subsequent FIGS. 39-48, the two parylene layers 203 and 210 bondedtogether are identified as their final form in the assembled array,passive side insulating layer 82. The layer of parylene disposed overthe side surfaces of the carrier 80 is considered part of the passiveside insulating layer 82.

The next step in this method of assembly 40 fabrication of thisinvention, is, as represented by FIG. 39, the formation of theelectrically insulating frame 83. Frame 83 may be formed from thematerial used to form the frame and using the processes described withrespect to FIG. 32.

Once frame 83 is formed, in this method of assembling array 40 a,control module 44 is seated in the opening defined by the frame 83 asdepicted illustrated with respect to FIG. 40. In FIG. 40, control module44 is shown not encased in a shell. In a variation of this method ofassembly of the invention, prior to the seating of the control module 44in the frame 83, the control module is at least partially encased in abiocompatible shell. For example, the shell may be formed from silicon.In versions of the invention in which the control module is so encasedin shell, the coupon 182 from which the carrier 80 is formed has athickness that is typically no more than 5 microns greater than thecombined top-to-bottom thickness of the control module and the shell.Thus, at this stage of the assembly process the top of the controlmodule 44 may be below the surrounding top surface of thecarrier-defining coupon 182.

Using a mechanical lapping process, the top section of thecarrier-defining coupon 182 and frame 83 are then removed so that, asdepicted by FIG. 41, the top surface of the coupon 182 is coplanar withthe exposed top surface of the control module 41.

A parylene coating is then applied to the exposed coplanar faces of thecontrol module 44 and the coupon 182, as represented by FIG. 42. Thisparylene becomes the parylene of intermediate insulating layer 92 andtherefore identified as such in FIGS. 42-48. As depicted in FIGS. 42-49the parylene forming layer 92, as well as the parylene forminginsulating layers 96, 99 and 110, extends beyond the top surfaces of thecarrier-forming features of the coupon. This parylene extends over slots184 (not illustrated) and slots 186. This parylene also extends over andinto windows 198 formed in the carrier 80. This parylene is bonds to theparylene of the previously applied passive side insulating layer 82. Asoccurs during the previously described method of manufacture, thesemulti-layer parylene laminates form the array membranes 70. The Whilenot illustrated, it should be understood from this Detailed Descriptionthat parylene forming layer 92 as well as the layers above layer 92extend between the outermost carrier tabs 194. These multi-layerparylene laminates form the array membranes 72.

Holes 239 (one shown), essentially identical to holes 138 of FIG. 11 areformed in insulating layer 92 to provide access to the underlyingcontrol module bond pads 91. The process used to form holes 239 is thesame as the process used to form holes 138.

The next series of steps in the assembly of the electrode array 40according to this method, represented by FIG. 43, is the formation ofconductors 46 and associated bus conductor. Conductors 46 are formedusing the same processes described with respect to FIGS. 12-15. In FIG.43 the initial titanium adhesion layer of the conductor is called out aslayer 242. The gold layer of conductor 46 is called out as layer 244.The topmost titanium layer is called out as layer 246. The gold appliedin the electroplating process used to form the largest section of layer244 flows into the holes 239 so as to form the vias 94. Formedsimultaneously with the conductors 46 is the conductor integral with bus118 to which the conductors 46 are connected. The same titanium, goldand titanium layers, 242, 244 and 246, respectively that form conductors46 form the conductor of bus 118.

As represented by FIG. 44, a layer of parylene is applied overconductors 46 and the exposed surfaces of the intermediate insulatinglayer 92 to form intermediate insulating layer 96. Holes 247 (oneshown), essential identical to holes 154 (FIG. 17) are formed to extendthrough insulating layers 92 and 96 to the control module contact pads91. This step is essentially identical to the step described byreference to FIG. 17 in which the 154 154 are formed.

Once the openings are formed in the intermediate insulating layers 92and 96, conductors 48 are formed. The process steps used to formconductors 48 are the same described with respect to FIGS. 17-19. InFIG. 45 the bottommost titanium layer of conductor 48 is called out aslayer 248. The gold intermediate layer is called out as layer 250. Thetopmost titanium adhesion layer is called out as layer 252. The goldapplied by the electroplating to form layer 250 also forms the vias 98.

During the process steps in which conductors 48 are formed, the titaniumand gold of layers 248, 250 and 252 is also deposited to from the bus118 conductor to which conductors 48 are connected. Thus, this conductoris like, conductors 48, disposed over intermediate insulating layer 96.

Assembly of electrode array 40 continues with the application ofparylene over the exposed surfaces of conductors 48, the bus conductorto which conductors 48 are connected and intermediate insulating layer96. This parylene, as seen in FIG. 46, forms the intermediate insulatinglayer 99. Once layer 99 is formed holes (one shown and not identified)are formed in the intermediate insulating layers 92, 96 and 99. Theseholes extend to bond pads 91 integral with the control modules 44.

Electrodes 42 are then formed on top of intermediate insulating layer99. The electrodes are formed in process steps analogues to the processsteps described with respect to FIGS. 21-23. A titanium adhesion layeris applied to the exposed surface of intermediate insulating layer 99. Agold seed layer is applied over the titanium layer. A mask is applied soas to have openings over where the electrode bond pads are to belocated. Gold is added to the exposed sections of the gold seed layer toform the layers 103. A portion of this gold also forms the vias 106.Titanium layers 104 are formed. The mask is removed. The sections offirst the gold seed layer and then the underlying titanium adhesion thatare not part of the base pads are then removed. Thus, as represented byFIG. 46, the electrode base pad consists of titanium layer 258, goldlayer 260 and titanium layer 262.

Fabrication of the electrodes 42 continues with the fabrication of thebuttons 107. Titanium is initially deposited over the exposed titaniumlayers 262 of the electrode base pads. Iridium is then deposited overthe titanium. In FIG. 47, as in FIG. 2, these layers are called out astitanium layers 108 and iridium layers 109.

Once the buttons 107 are formed, as represented parylene is applied tothe exposed surfaces of the electrodes 42 and the intermediateinsulating layer 99 to form the outer insulating layer 110, asrepresented by FIG. 48. Portions of the insulating layer 110 are removedover electrode buttons 107 to provide the openings 112 through which thebuttons are exposed to the tissue.

The essentially completely assembled electrode array 40 a is thenremoved from the coupon 182 and substrate 206. The process steps used toaccomplish these separations are identical to those described withrespect to FIGS. 34-37. These process steps include the steps ofselectively removing the parylene so as to uncover the slits 184 and 186around and in the carrier. Tabs 204 are removed. A layer 216 of paryleneis applied so as to cover the exposed surfaces of the carrier.Sacrificial layer 208 is removed to allow the array 40 a to be lifted ofthe substrate 204.

In this method of assembling the electrode array 40, the control modules44 are seated in the carrier during an initial step of assembly process.The application of the insulating layers 92, 96, and 99 over thesubstrate can be considered the formation of a flexible sheet ofinsulating material over the substrate. The insulating and conductivelayers that collectively define the array 40 electrodes, conductors andvias are formed on the carrier. Thus, in this version of the inventionthe process steps associated with having to bond an electrode andconductor sub assembly to the carrier are eliminated.

IV. First Alternative Electrode Array

FIG. 49 illustrates in cross section a portion of an alternativeelectrode array 40 b of this invention. Electrode array 40 b of thisinvention includes the same electrode, control module 44 and carrier 80of the previously described versions of this invention. Array 40 bincludes the previously described conductor 48 and insulating layers 82,92, 96, 99, 110 and 216 (layer 216 not illustrated.)

Instead of the previously described conductors 46, array 40 b includes aconductor 282. Conductor 282 extends from a bond pad 91 integral withthe control module 44 over a section of intermediate insulating layer 92to a location over the carrier. In FIG. 49, conductor 282 is shownextending over the carrier tab 194 in which the control module 44 withwhich the conductor 282 is seated. A via 284, which extends throughintermediate insulating layer 92, connects the end of conductor 282 tothe carrier 80.

In this version of the invention, the carrier 80, which is formed fromconductive material, functions as the common ground plane for theplurality of control modules 44. Consequently, as seen in FIG. 50, array40 b is constructed so that a one-wire bus 288 functions as the conduitover which power and control signals are transmitted to the plurality ofcontrol modules 44.

V. Second Alternative Electrode Array

A second alternative electrode array 310 of this invention is nowdescribed by initial reference to FIGS. 51-53. Array 310 includes acarrier 312 that is at least flexible, if not superelastic. Carrier 312is formed to have plural pairs of contiguous tabs 314 (FIG. 54A). Apairs of electrodes 316 are disposed over each contiguous pair of tabs314. A control module 318 (ASIC) is disposed seated in each pair ofcarrier tabs 314. Each control module 318 is thus located below a pairof electrodes 316. Each control module 318 includes the components thatsource current to/sink current from the overlying electrodes 316.

Each pair of carrier tabs 314 and associated control module 318 aredisposed over a ceramic substrate 320. Substrate 320 is formed with vias445 and 447 and conductors 443 (FIG. 58) that provide conductive pathsto/from the control module 318. The control module 318 is substantiallyencased in synthetic resin shell 328. Shell 328 forms a non-porous sealaround substantially the whole of the control module 318. A ring 330extends around the outer perimeter of shell 328. A lid 332 extends overthe top of shell 328 and the top face of ring 330.

A ceramic superstrate 336 extends over each pair of contiguous carriertabs 314 and the associated control module 318. The electrodes 316 thatform each pair of array electrodes are formed on the outer exposedsurface of substrate 336. Vias 338 (FIG. 60) extend through substrate336 to provide electrical connections to/from the electrodes 316.

Carrier 312 is disposed within a flexible, electrically insulating,non-porous laminate 340. In one version of the invention, laminate 340is formed from plural layers of liquid crystal polymer (LCP). Laminate340 is formed with conductors 342 (FIG. 66). The laminate conductors 342are formed on one of the surfaces of a laminate-forming layer 484 ofLCP. Conductors 342 form sections of the electrical paths to/from thecontrol modules 318.

Posts 344 extend between each substrate 320 and the overlyingsuperstrate 336 through the intermediate laminate 340. The posts 344serve as conductive paths to/from the electrodes 316 and the controlmodules 318. At least some of the conductors 342 are electricallyconnected to posts 344. Posts 344 also function as structural membersthat hold the substrate 320 and superstrate 336 to the other layers ofcomponents that form the electrode array 310 of this invention.

A solder plug 472 disposed on superstrate 336 is bonded to lid 332.Solder plugs 472 thus further hold the superstrates 336 to the rest ofthe array 310.

Electrode array 310 is further formed to have a base 347 that forms themost proximal end of the array. Cable 50 extends from array base 347. Atthe most proximal end, electrode array 310 is formed to have a head 354and two opposed shoulders 355. Head 350 and shoulders 351 are analogousto head 74 and shoulders 76 of array 40.

VI. Method of Assembling the Second Alternative Electrode Array

The fabrication of electrode array begins with: the fabrication of thecarrier 312; the fabrication of the control module 318; the fabricationof the substrates 320 and superstrates 336; and the fabrication of thecarrier-laminate sub-assembly. Fabrication of these components canessentially occur simultaneously and independently of each other. Oncethese components are available, the control module 318 is mounted to thesubstrate 320. Shells 328 are formed over the control modules 318. Thecontrol module-substrate sub-assemblies are then fitted to thecarrier-laminate sub-assembly. The superstrates 336, with the electrodes316 already formed thereon, are seated on top of the control modules 318and the laminate 340. Posts 344 are then formed.

Carrier 312 is formed from the same material from which carrier 80 (FIG.26) is formed. Carrier 312 has a thickness of approximately 50 microns.The same method used to form carrier, 80, selective etching of materialforming a coupon, is used to form carrier 312. FIGS. 54 and 54Aillustrate one version of a carrier 312 of this invention formed withina coupon 370. Carrier 312 is formed so that the pairs of tabs 314 arearranged in a 9×3 array wherein there are nine longitudinally spacedapart rows of pairs of tabs 314. Each row tabs 314 contains three pairsof contiguous tabs 314. At the proximal end, carrier 312 is shaped tohave a base 372 in which the three most proximal pairs of tabs 314 areformed. Carrier base 372 forms the foundation for array base 347.Proximal to the most proximal row of tabs 314, carrier base 372 isformed to have two openings 374, 378 that define a tab 376. Tab 376 iscentered along the longitudinal axis that separates the tabs 314 theform the center pair of tabs 314. Tab 376 is located proximal to themost proximal row of tabs 314. Given that tab 376 is proximal to themost proximal row of tabs 314, tab 376 is the most proximally locatedtab on carrier 312.

Within each column of tabs 314, a bridge segment connects each pair oftabs with the longitudinally adjacent pair (or pairs) of tabs. In FIGS.54 and 54A bridge segments 382 (two identified) connect the adjacentpairs of tabs 314 in the left most column. Bridge segments 384 (twoidentified) connect the adjacent pairs of tabs 314 in the center columnof tabs; and bridge segments 386 (two identified) connect the adjacentpairs of tabs 314 in the right most column of tabs. The plural bridgesegments forming each set of bridge segments 382, 384 are 386 arelongitudinally aligned. Bridge segments 382, 384 and 386 are parallelwith each other.

The carrier 312 is further formed to have beams 388 similar to beams 196of carrier 80. Beams 388 extend between laterally adjacent bridgesegments 382, 384 and 386. Each beam 388 that extends between a bridgesegment 382 and the adjacent bridge segment 384 is collinear with anadjacent beam 388 extending between the same bridge segment 384 and theadjacent bridge segment 386. Each end of each beam 388 projects awayfrom where the adjacent bridge segment 382, 384 or 386 extendslongitudinally away from one of the associated pairs of tabs 314.

There is only single pair of aligned beams 388 associated with the mostproximal row of tabs 314. These beams are located immediately forward ofthe tabs 314. There are two rows of beams 388 associated with each ofthe remaining rows of tabs 314. One pair of aligned beams 388 is spaceda short distance rearward from proximal ends of the tabs 314. The secondpair of aligned beams is spaced a short distance distally forward of thedistal ends of the tabs 314.

Given that each row of tabs 314 is spaced apart from the longitudinallyadjacent row of tabs, it should be appreciated that each pair of alignedbeams 388 is spaced away from the longitudinally adjacent pair ofaligned beams 388. This spacing is between approximately 0.5 and 5.0 mmand often between 1.0 and 3.0 mm.

From FIG. 54A it will be observed that tabs 314 that extend outwardlyfrom adjacent bridge segments 382 and 384 and from adjacent bridgesegments 384 and 386 are spaced apart from each other. Further, asmentioned above, beams 388 are spaced away from the tabs 314. Thisfeature spacing on the carrier serves to define within each row of tabstwo I-shaped slots 387.

The carrier 312 is further formed so as to have a head 392 and shoulders394. Head 392 and shoulders 394 for the rigid foundation for array head350 and shoulders 351.

During the formation of carrier 312, the material forming the carrier isremoved so as to form in each pair of contiguous tabs 314 three windows402, 404 and 406. The longitudinal axes of windows 402, 404 and 406 areparallel with each other and parallel with the longitudinal axis of thecarrier 312. Each row of windows 404 is centered on the line that couldbe considered the border between the contiguous pair of tabs 314. Thisline is also the axis line that extends through the associated set ofbridge segments 382, 384 or 386. Window 404 is dimensioned so that whenthe carrier 312 is disposed over the control module 318, there is aseparation of at least 25 microns between the outer surface of ring 330and the border of the window 404. Windows 402 and 406 are laterallyspaced away from the opposed sides of window 404. Each window 402 and406 is therefore completely contained in one of the tabs 314 that formthe contiguous pair of tabs. Windows 402 and 406 are spaced apart thesame distance from window 406. Windows 402 and 406 are longer in length,(the dimension parallel to the longitudinal axis of the carrier) andshorter in width (the dimension perpendicular to the longitudinal axisof the carrier) than the associated window 406. In some versions of theinvention each window 402 and 406 defines an area of approximately 200microns by 4000 microns.

In FIG. 54A, for point of reference, the outlines of two electrodes 316that form a pair of electrodes are shown as dashed lines

Once portions of coupon 370 are etched to form the carriers 312, anelectrically insulating coating is disposed over the coupon. In oneversion of the invention this coating is a silicon oxide coating that isapproximately 500 Angstroms thick. This coating is applied by a plasmadeposition process. This coating is applied to the coupon 370 so as tocover all the exposed surfaces of the carriers 312 formed by the coupon.In FIG. 64 this coating is seen as layer 414 over a pair of contiguoustabs 314 of a coupon. The layer 414 is thus seen as extending over thetop and bottom major surfaces of the tabs 314, the opposed side facesand the interior faces of the tabs that define windows 402, 404 and 406.For ease of illustration only, this coating is only in FIGS. 64 and 68.

Control module 318 is similar to control module 42. Control module 318is formed to have plural current sources and plural current sinks. Thesources and sinks are of the type that allows the quantities of currentsourced by/sunk to the module 316 to be adjusted. Plural sources andsinks are provided so that simultaneously different quantities ofcurrent can be sourced from/sunk to the individual electrodes 316 towhich each control module 318 is connected. Each control module 318 mayalso include one or more circuit components that facilitate themeasurement of the voltage present at each electrode 316 with which thecontrol module is associated.

Semiconductor fabrication techniques not part of the current inventionare employed to fabricate the control modules 318. As represented byFIG. 55, typically, plural control modules 318 are formed on a singlesilicon wafer 420. Often, wafer 420 has an initial thickness ofapproximately 550 microns. During the processes of module formation,each control module 318 is typically formed to have a number of bondpads 422 as seen in FIGS. 56 and 57. In FIG. 57 the bond pads 422 areshown as being elevated relative to the adjacent surface of the modulewith which the pads are integral. This is for ease of illustration only.Often the bond pads 422 are essentially flush with the surroundingsurface of the control module 318. Each bond pad 422 is a location onthe surface of the module 318 wherein a specific signal is applied to oroutputted from the module. While the control modules 318 are stillintegral with wafer 420, electrically conductive solder bumps 426 aredeposited over each bond pad 422. Solder bumps 426 are formed from goldand are applied to the associated bond pads 422 by a bump bondingprocess. Each solder bump 426 typically extends approximately 12 micronsabove the associated bond pad 424.

Once solder bumps 424 are formed, the overall thickness of the wafer 420is reduced. This step is performed by back grinding and polishing theface of the wafer opposite the face on which the control modules 318 areformed. This back grinding and polishing is performed to remove thesilicon so that the overall thickness of the wafer is reduced toapproximately 50 microns. Wafer 420 is then diced to remove theindividual control modules 318. After conventional testing, the controlmodules 318 are ready for bonding to the substrates 320.

Both the substrates 320 and superstrates 336 are formed fromelectrically insulating rigid members that have at least one non-porouslayer. In one version of the invention, substrates 320 and superstrates336 are both formed from a low temperature cofired ceramic. Often, oneor both of substrate 320 and superstrate 336 are formed out of multiplelayers of ceramic using processes that are not part of this invention.As is apparent from the description above, electrode array 310 includesplural substrates 320 and plural superstrates 336. There is onesubstrate-superstrate pair for each pair of contiguous tabs 314.Accordingly, it is the practice to simultaneously fabricate the pluralsubstrates 320 together as single ceramic wafer. The plural superstrates336 are likewise formed together on a common ceramic wafer. (Wafers notillustrated.) Each wafer typically has an initial thickness of 500microns.

Plural layers of low temperature cofired ceramic may be used to formeach wafer. Specifically with regard to the substrate 320, a bottomlayer of ceramic material, layer 442 in FIG. 58, is provided withconductive traces 443. The topmost layer of the substrate formingceramic, layer 444, is provided with electrically conductive vias 445and 447. Vias 445 are positioned so that when the control module 318 ispositioned on the substrate 320, the control module stud bumps 426 aredisposed over the exposed faces of the vias 445. Each via 445 extendsthrough the associated ceramic layer 444 to the end of one of theconductive traces 443. Each via 447 extends though ceramic layer 444 toan end of a conductive trace 443 opposite the end to which acomplementary via 445 abuts. For ease of illustration, conductors 443and vias 445 and 447 are seen only in FIGS. 58, 59 and 78.

The top most substrate wafer-forming ceramic layer is further formed tohave on its exposed face a metal ring 448. Substrate ring 448 is in theform of a rectangle with rounded corners. Ring 448 is dimensioned sothat the control module 318 can be disposed within the ring and, whenthe control module is positioned there is a spacing of at least 100microns from the control module and the ring. Further, each substrate320 is formed so that the exposed faces of vias 445 are within ring 448.Vias 447 are positioned to so as to have exposed faces spaced beyond theouter perimeter of substrate ring 448.

Once the wafer containing the plural substrates 320 is formed, theoverall thickness of the wafer is reduced. This process is performed byback grinding the outer face of the wafer, the side opposite the face towhich the vias 445 and 447 extend and on which the ring 448 is formed.In some versions of the invention, this back grinding is performed toreduce the thickness of the substrate-carrying wafer to 100 microns.

The outer face of the substrate carrying wafer is then polished. Often,this polishing is a two step process. In the first step, a low gritabrasive paper is applied to the face at a relatively low speed. Thisresults in a fine layer of ceramic particles forming on the outer faceof the wafer. Then, a higher grit abrasive paper is applied to the waferat a higher speed. The heat generated by this polishing step causes theceramic material to which the abrasive paper is applied to enter asemi-solid. This ceramic material, both the material still part of thewafer and the free particles, fuse together to form a non-porous barrierlayer immediately below the outer surface of the wafer. In FIGS. 59,this non-porous layer is illustrated as layer 449, the layer below thelower most dashed line that extends horizontally across substrate 320.Given the non-porous nature of this layer 449, this layer formsessentially a liquid and gas tight barrier over the outer surface of thesubstrate 320. For ease of illustrate this non-porous layer 449 is onlyillustrated in FIG. 59.

In some methods of manufacture of this invention, the inner surface ofsubstrate carrying wafer is also polished. This surface is polishedusing the previously described steps to polish the wafer outer surface.Interleaved with the actually polishing steps is the rinsing of thesubstrate-carrying wafer. This rinsing removes debris including any goldseparated from the vias 445, 447 and substrate ring 448. As aconsequence of the wafer being exposed to this polishing, a non-porousbarrier layer forms immediately below the inner surface of the wafer. InFIG. 59, this surface is illustrated as layer 450, the layer above thetop most dashed line that extends across the substrate 320. Layer 450,like layer 449, forms a barrier layer that, if not gas tight is liquidtight. Again, for ease of illustration only, layer 450 is onlyillustrated in FIG. 59.

Once the polishing of the substrate-carrying wafer is complete,containment ring 330 and solder plugs 451 and 453 are formed on theinner surfaces of the individual substrates 320. Containment ring 330 isdisposed over substrate ring 448, (interface not seen in FIG. 59). Eachsolder plug 451 is disposed one of the vias 445. Each solder plug 453 isdisposed over one of the vias 447.

Containment ring 330 and solder plugs 451 and 453 each includes a layerof titanium 439 disposed directly over the gold face of the underlyingvia 445 or 447. The titanium layers 439 are at least 300 Angstromsthick. Titanium layers 439 are applied by a vapor deposition process. Aplatinum layer 452 500 Angstroms thick is applied over the titaniumlayer 439 by a vapor deposition process. A layer of gold 454,approximately 5 to 20 microns thick is applied over the platinum layer452 by an electroplating process. The depositing of the gold layers 454completes the formation of solder plugs 451. In FIG. 59, only the goldlayer 454 associated with a single one of the solder plugs 451 isidentified.

Fabrication of the containment ring 330 and solder plugs 453 continueswith the application of an additional gold on gold layers 454. This goldis applied by a second electroplating process. This gold combines withthe gold of layers 454 to provide the containment ring and each of thesolder plugs 453 a gold layer, layer 455 in FIG. 59, that has athickness, (a height) of approximately 50 microns. This second layer ofgold is not applied to the whole of the gold layer 454 initiallydeposited on the substrate to form the containment ring 330. This goldis deposited inwardly approximately 25 microns of the outer perimeter ofthe layer 454. These contiguous gold layers of containment ring 330define a step 456, seen only in FIGS. 59, and 70, that is locatedinwardly of the outer perimeter of the containment ring.

Layers of platinum 456 and gold/tin solder 461 are applied to the topsurface of the gold layers 455. Platinum layer 457 has the samethickness as platinum layer 454 and is applied by the same processemployed to deposit layer 454. The gold/tin solder layers 461 have athickness of 25 microns and are applied by an electroplating process.

Gold layers 454 provide height to the solder plugs 451. Gold layers 455,combined with the gold of layers 454 provide height to both thecontainment ring 330 and solder plugs 453. During subsequent thermalcompression processes described below, solder layers 461 integral withthe solder ring 452 liquefies to bond to shell 344. Solder layers 461bond with superstrate solder plugs 471 to form posts 344. Platinumlayers 457 prevent the gold internal to the layer 455 from leaching intothe solder. Platinum layers 452 prevent upward leaching of the titaniumof layers 439. The titanium layers 439 themselves are provided becausethey adhere well to both the gold of the underlying vias 445 and 447 andring 448 of the substrate 320 and to platinum. For ease of illustration,other than in FIG. 59, containment ring 330 and solder plugs 451 and 453are shown as single metal members.

Once the solder plugs 451 and 453 and the solder ring 452 are formed onthe substrates 320, the substrate-carrying wafer is diced. The dicingseparates the wafer into the individual substrates 320. During thedicing process, the saw that performs the dicing heats the sidessurfaces of the substrates 320. These surfaces are heated to the levelwhere the ceramic material forming the outer side layers transitions tothe semi-solid state. As when the ceramic is polished, this heatingallows the outer layer of ceramic material to fuse together so as toform a non-porous barrier layer. In FIG. 59, these layers 459, shownimmediately inward of the outer side surfaces of the substrate 320. Forease of illustration, these non-porous layers are only illustrated inFIG. 59.

The ceramic wafer forming the superstrates 336 is fabricated so that, asseen in FIG. 60, each superstrate has two conductive vias 462. Eachsuperstrate 336 is formed so that each via 462 extends top to bottom,through the superstrate. More specifically, each via 462 is locatedunder an outer surface of the superstrate over which a separate one ofthe electrodes 316 is subsequently formed. For ease of illustration,each via 462 is seen only in FIG. 60.

Once the superstrate-carrying wafer is formed, the outer surface of thewafer, the surface on which the outer surfaces of the superstrates 336lie, is polished. This surface is polished using the same polishingsteps used to polish the substrate-carrying wafer. This polishing isperformed to form non-porous outer layers on the superstates 336. Onesuch layer, layer 465 is seen in FIG. 62 as being the layer ofsuperstrate-forming ceramic above the top most dashed line that extendsacross the superstrate 336.

Once the superstrate 336 is polished, the electrodes 316 are formed onthe outer surface. Fabrication of the electrodes 316 starts with thedepositing of gold layers 466 on the exposed faces of barrier layers465. Gold layers 466 are applied by electroplating or thick film screendeposition process and have a thickness of at least 250 microns. Itshould be appreciated that each one of the gold layers 466 overlies andbonds with the exposed face of one of the superstrate vias 462. Goldlayers 466 are applied to the superstrate because the gold adheres wellto the exposed face of the ceramic barrier layers 465. A layer ofiridium, layer 467, is deposited over each of the gold layer 466. Theiridium is applied to a thickness of at least 5 microns. The iridium isapplied by a sputter process. The iridium forms the low-impedance highcharge capacity exposed face of each electrode. Collectively, each goldlayer 466-iridium layer 467 laminate forms a single electrode 316. Inone version of the invention, each electrode 316 has a surface area ofapproximately 1.0 mm by 4.0 mm. The two electrode 316 are deposited onthe superstrate-carrying wafer are deposited so that the two electrodes316 that form the pair of electrodes on a single superstrate 336 arespaced apart by at least 250 microns. In the Figures other than FIG. 62,for ease of illustration only, electrodes 316 are shown in cross sectionas consisting of a single metal layer.

The overall thickness of the substrate-carrying wafer is then reduced.Specifically, using a back grinding process the overall thickness ofthis wafer is reduced to approximately 100 microns. This process isperformed on the inner side of the wafer, the side with the faces of thesubstrates 336 that will eventually be directed toward carrier 318 andthe control modules 318. Then, using the previously discussed polishingprocess, the inner side of the wafer is polished to form a non-porouslayer. This layer is called out in FIG. 62 as layer 468 below the lowerof the two dashed lines that extends across the superstrate 336.

Non-porous superstrate layers 465 and 468, like non-porous substratelayers 449 and 450 are liquid tight if not gas tight.

Solder plugs 471 and 472 are then formed on the inner surface of thesuperstrate-carrying wafer. As seen in FIG. 61 there are plural smallsized solder plugs 471 and one large sized solder plug 472. Two of thesolder plugs 472 are disposed on the exposed faces of the vias 462 thatextend through the substrate. (Interface not illustrated.) Threeadditional solder plugs 471 are formed on the face of substrate layer468 so as to be in line with each via-covering solder plug 472. Solderplug 472 is in between the two rows of solder plugs 471. Solder plug 472is positioned so that when the superstrate 336 is disposed over thesubstrate 320, the plug 472 is disposed over lid 332. Solder plug 472 isformed to have an outer perimeter that extends between 5 to 150 micronsoutwardly from the outer perimeter of the lid 332.

Solder plugs 471 and 472 are formed by initially applying a layer 470 oftitanium on the locations on the substrate layer 468 on which the plugsare to be formed. This includes the exposed faces of the vias 462. Thetitanium is deposited using vapor deposition process layers so as tohave a thickness of at least 300 Angstroms. Platinum layers 477 having athickness of 500 Angstroms are applied over the titanium layers 470.Platinum layers 477 are applied using a vapor deposition process. Goldlayers 478 have a thickness of at least 10 microns are applied over theplatinum layers 477 using an electroplating process. Platinum layers 479are deposited over gold layers 478. Platinum layers 479 have the samethickness as platinum layers 477 and are applied using the same processused to deposit layers 477. Gold/tin solder layers 493 that have athickness of at least 10 microns are deposited over platinum layers 479using an electroplating process.

Titanium layers 470 are applied because they adhere well to both ceramicand the subsequently applied metal. Platinum layers 477 and 479 areapplied to prevent the gold of layers 478 from leaching during thesubsequent solder bonding process. The gold layers 478 themselvesprovide height to the solder plugs 471 and 472. The gold/tin alloy ofsolder layers 493 are the layers of the solder plugs 471 and 472 thatactually bond with the structural members against which the plugs laterabut.

At this stage in the process of fabricating the superstrates 336, thesuperstrates are ready for separation from the wafer. This process isperformed by dicing the wafer. The saw employed to separate thesubstrates 336 from the wafer, and from each other, heats the surfacesof the substrates to which the saw is applied. This heating causes thematerial forming to substrate to transition to a semisolid state andfuse together. This fused ceramic material thus forms non-porous layersalong the side surfaces of the superstrate 336. In FIG. 62 these layersare called out as layers 473. Layers 473, like layers 465 and 468,prevent at substantially all liquid flow, if not gas flow, into thecenter of the superstrate 336.

FIG. 63 illustrates how the carrier 312 is embedded in the electricallyinsulating laminate 340. The laminate 340 consists of three layer offlexible, electrically insulating material, here liquid crystal polymer(LCP). Laminate 340 includes a bottom layer 482, a middle layer 484 anda top layer 486. Each layer 482, 484 and 486 has a thickness ofapproximately 25 microns. As seen by reference to FIG. 64, collectively,carrier 312 and laminate 340 are assembled so that the carrier isdisposed between the bottom and middle laminate layers 482 and 484,respectively.

The features of laminate bottom layer 482 are now described by referenceto FIG. 65. Layer 482 has an outer perimeter with a shape similar tothat of the carrier 312 disposed over the layer. While carrier 312 andlaminate layer 482 have the same generally shape, the laminate layer hasa surface area slightly larger than that of the carrier 312.Specifically the relatively dimensions of these components are such thatwhen the carrier 312 is disposed over the laminate layer 480, thelaminate layer extends approximately 25 microns beyond the outerperimeter of the carrier. Also, unlike the carrier 316, the sides of thelaminate bottom layer 482 do not bend inward at the locations where tabs314 are not present.

Laminate layer 482 is further formed with plural, longitudinally spacedapart rows of rectangular windows 490. Laminate layer windows 490correspond in number and arrangement to carrier windows 404. Thelaminate layer window 490 have shape and a cross sectional area thatcorresponds to the shape and area of the carrier windows 404. Adjacentthe longitudinal sides of each window 490, laminate layer 482 is furtherformed to have a row of openings 492. Openings 492 are located so thatwhen the adjacent laminate window 490 is in registration with a carrierwindow 404, one row of openings is centered under the complementarycarrier window 402 and the second row of openings is centered under thecomplementary carrier window 406. Openings 492 are circular in shape.The openings 492 have a diameter that is approximately 10 microns lessthan the width across the associated carrier window 402 or 406.

The bottom laminate layer 482 is also shaped so as to have pluralI-shaped slots 494. Within each row of windows 490 there are two slots494. Each slot 494 is located between the two windows 490 that form apair of adjacent windows 490. Each slot 494 is located so that when arow of laminate windows 490 is in registration with a row of carrierwindows 404, each slot is in registration with the I-shaped slot 387between adjacent carrier tabs 314. The widths across the sections ofeach slot 490 are approximately 25 microns less than widths across thecorresponding sections of the carrier slots 387.

Laminate layer 482 is further formed to have forward of the distal end,two asymmetrically shaped windows 495 and 496. Windows 495 and 496define a tab 498 (FIG. 63) internal to the laminate layer that willoverlie carrier tab 376. The distal end of laminate layer 482 is formedto have two slots 504. Slots 504 have shapes that correspond to the voidspaces in the carrier 312 between the head 392, shoulders 394 andproximal most beams 388. Slots 504 are approximately 25 microns less inwidth than the underlying void spaces in the carrier 312.

The middle layer of laminate 340, layer 484 has the same basic shape andfeatures as layer 482. The dimensions of the features of middle layer484 are identical to those of bottom layer 482. Layer 484, now describedby reference to FIG. 66, is formed with windows 508 and slots 509 and510. Middle layer 484 windows 508 and slots 509 and 510, correspond,respectively to, bottom layer 482, windows 490 and slots 494 and 504.Laminate middle layer 484 is further formed with through openings 512that correspond in number and position to openings 492 internal to layer482.

Laminate layer 484 is further formed to have slots 514 essentiallyidentical to slots 494 internal to layer 482. It can be seen from FIG.63 that laminate layer 484 is further shaped to define a tab 511analogues to the tab 498 integral with layer 482.

Conductors 342 and complementary capture pads 515 are formed on laminatemiddle layer 484. The capture pads 515 are disposed around layeropenings 512. Capture pads 515 are ring shaped and disposed on theoutwardly facing surface of layer 482, the surface directed away fromthe control module 318. The conductors 342 extend to the capture pads515. In FIG. 66, for ease of illustration, only a few of the conductors342 that extend away from just several of the capture pads 515 areillustrated.

Each conductor 342 and capture pad 515 is in form of a laminatestructure as seen in FIG. 66A. Both the conductors 342 and capture pads515 have bottom layers 485 formed from titanium. Titanium layers 485have a thickness of at least 300 Angstroms and are applied using a vapordeposition process. Conductors 342 and capture pads 515 have commonco-planar gold layers 487. Gold layers 487 have a thickness of at least2 microns and are applied using an electroplating process. Conductors314 have a top layer, layer 489 of titanium. Layer 489 has the samethickness as titanium layer 485 and is applied using the same process.Capture pads 515 have a top layer, layer 491 formed from platinum. Theplatinum of layer 481 has a thickness of at least 1 micron and isapplied using a vapor deposition process.

Titanium layers 485 are provided because titanium adheres well to bothLCP and gold. The gold of layers 487 are the highly conductive layers ofthe conductors 314 and capture pads 515. The conductors 314 are providedwith the top most titanium layers 489 because the titanium bonds well tothe laminate top layer 486 that is subsequently affixed over theconductors. As described below, in a later step of the process ofassembling electrode array 310, capture pads are bonded to superstratesolder plugs 471. During this bonding process, the platinum outer layers491 of the capture pads 515 prevent the underlying gold from leaching.

Laminate top layer 486 is essentially identical in shape to laminatebottom layer 482. The outer perimeter of the top layer 486 has the samedimensions as the bottom and middle layers 482 and 484, respectively.Most of the windows, slots and openings in laminate top layer 486 areidentical dimensions to those in the bottom layer 482. Accordingly,these identical features are not called out. One difference between thetwo layers 482 and 486 is the openings 518 in top layer 486, identifiedin FIG. 64. Openings 518 correspond to the openings 492 in bottom layer482. A difference between the two sets of openings is that openings 518are appreciably larger in diameter than openings 492. Generally, itshould be appreciated that openings 518 are larger in diameter than thediameter of the capture pads 515. In some versions of the invention, toplayer openings 518 have a diameter 25 microns or greater than thediameter than the middle layer capture pads 515.

To facilitate the batch manufacture of electrode arrays 390 of thisinvention, typically plural laminate 340-forming layers are formed on asingle sheet of LCP. As represented by FIG. 67, plural bottom layers 482are formed on a single sheet 522 of LCP. Openings are formed in thesheet 522 to form the features of the individual layers 482 by a laseretching process. While only partially shown in FIG. 67, small tabs (notidentified) hold the essential formed laminate layers 482 to the rest ofthe sheet 522. Sheets of LCP similar to sheet 522 are shaped to form,respectively, the plural middle layers 484 and plural top layers 486.

The carrier-laminate sub-assembly is fabricated by placing thecarrier-containing coupon 370 over the LCP sheet on which the laminatebottom layers 482 are formed. The LCP sheet on which the laminate middlelayers 484 are formed is placed over the exposed face of the coupon 370.The LCP sheet on which the laminate top layers 486 are formed is placedover the exposed face of the middle layer sheet. Thus, the sheet ofupper laminate layers 486 is disposed immediately over conductors 342.As a consequence of this arrangement, it should be understood that thecarrier windows 404 are in registration between the laminate layerwindows 490 and 508. The large windows integral with top laminate layer486 are immediately above the middle layer windows 508.

The laminate layers 482, 484 and 486 are then bonded together using avacuum controller thermal compression process. As a consequence of thisprocess, as seen in FIG. 64, the ends of the laminate bottom and middlelayers 482 and 484, respectively that project beyond the outerperimeters of the carrier tabs 314 bond together. Each carrier 312 isthus partially encapsulated within the surrounding laminate layers 482and 484. The side surfaces of the carrier 312 that defines windows 404are not so encapsulated. These surfaces of each carrier are electricallyshielded by oxide coating 414.

Also as a consequence of this bonding process the laminate top layers486 are bonded over the laminate middle layers 484. Conductors 342 aresandwiched between laminate layers 484 and 486. In FIG. 64, for ease ofillustration, conductors 342 are not shown. Owing to the relativedimensioning of middle layer openings 512 and top layer openings 518,capture pads 515 are exposed.

LCP layers 482, 484 and 486 forming laminate 340 are not formed so as tobe continuous between the adjacent longitudinally spaced apart slots494. Thus, when the laminate 340 is bonded over and under the carrier,sections of LCP extend over the void spaced between longitudinallyadjacent carrier beams 388. These unbroken sections of laminate formmembranes 528 (FIG. 51) that extend under/over the interior sections ofthe carrier. These membranes 528 are analogues to membranes 70.Similarly, unbroken sections of laminate extend longitudinally betweenthe longitudinally adjacent tabs that form the two opposed outermostrows of tabs. These sections of laminate function as membranes 529 (FIG.51) analogues to membranes 72.

As a further result of the encapsulation of carrier 312 in laminate 340,laminate layers 482, 484 and 486 extend over and under carrier windows402 and 406 as seen in FIG. 68. Within each window 402 and 404, thelaminate layer 482 bonds to the overlying laminate layer 484. Owing tothe registration of the laminate layers 482, 484 and 486 with eachother, laminate bottom layer openings 492, middle layer openings 512 andupper layer openings 518 go in registration with each other. Further, aspart of the carrier encapsulation, the laminate layers 482, 484 and 486flex into the space defined by the carrier window 402 or 406. A plasticrib 521 is fitted into each window 402 and 404 adjacent the exposedsurface of the laminate bottom layer. The rib 521 pushes the sections oflaminate 340 disposed in the associated window 402 or 406 outwardly.Thus the tops of the laminate sections disposed over windows 402 and 406are essentially flush with the surrounding sections of the laminate. Onthe substrate-facing surface side of the carrier-laminate sub-assembly,ribs 521 have exposed faces that are essentially flush with the adjacentsurfaces of the laminate. Ribs 521 thus ensure that, when acarrier-laminate is disposed between a substrate 320 and a superstrate336, essentially the whole of one face of the carrier-laminate abuts thesubstrate 320 while the whole of the opposed face abuts the superstrate336.

Ribs 521 are formed with through bores 523. Bores 523 are positioned sothat when the rib is fitted in a carrier window 402 or 406, the bore isaligned with the coaxial laminate openings 494. 512 and 518.

Once the carrier-laminate sub-assemblies are formed, the assemblies areexcised from the flexible coupon and the sheets of electricallyinsulating material.

The fabrication of the sub-assemblies forming the electrode array 310into the array, as represented by FIGS. 70 and 71, starts with thebonding of the control module 318 to substrate 320. The control module318 is disposed inside ring 330 so that the module stud bumps 424 aredisposed over the substrate solder plugs 453 formed over vias 447. Athermal compression bonding process bonds the opposed contacting pairsof stub bumps 424 and solder plugs 453 together. This bonding bothsecures the control module 318 to the substrate 320 and establishes theelectrical connections between the substrate bond pads 422 to thesubstrate vias 445. For ease of illustration, each bonded solder bump424-solder plug 453 unit is shown as a single section of material.

Using a plasma deposition process, silicon oxide is then deposited onthe inner surface of substrate 320. As seen by reference to FIG. 72, thesilicon oxide 532 flows into the space between the control module 318and ring 330. To the extent there are small space, typically, 15 micronsor less, between the inner surface of the substrate 320 and the adjacentunder surface of the control module 318, the silicon oxide 532 alsoflows into this space. In the Figures the separation between the controlmodule 318 and the substrate 320 is exaggerated for the purposes ofillustration. In this deposition process, the silicon oxide 532 isdeposited so as to extend above ring 330. In some versions of theinvention, the silicon oxide extends approximately 50 microns above theexposed face of ring 330. Silicon oxide is a conformal coating that,when deposited is substantially impenetrable to fluid flow therethrough.

As illustrated by FIG. 73, the upper portion of the silicon dioxidelayer 532 is then removed. This step may be performed by back grinding.More particularly, the silicon dioxide layer 532 is removed to the levelat which the layer 532 is planar with the top of ring 330. This step isperformed to ensure that, within the ring 330, the silicon dioxide layer532 does not project above the ring 330 and is planner.

Lid 332 is then secured over ring 330. As represented by FIG. 74, aninitial step in the mounting of lid 330 is the depositing of a layer oftitanium 534 over the exposed face of the silicon oxide layer 532.Titanium layer 534 has a thickness of at least 0.3 microns and isdeposited using a vapor deposition process. The titanium forming layer534 bonds to the exposed face of ring 330 and the exposed face of theco-planar silicon dioxide layer 532. A layer of gold 536 approximatelyat least 0.3 microns thick is then applied over titanium layer 534 usinga vapor deposition process.

Titanium and gold layers 534 and 536, respectively are then removedother than where the lid 332 is to be bonded to the sub-assembly. Thisprocess is performed by first applying a layer of photoresist 538 overthe exposed section of the gold layer 490 where the lid is to beaffixed. This area is the area defined by and within ring 330. Using achemical etching process, the titanium layer 534 and gold layer 536 areremoved. At this time, while the photoresist layer 538 remains in place,using a reactive ion etching process, the silicon dioxide layer 532 notcover by the photoresist layer is removed. The remaining silicon oxideis the silicon oxide disposed within ring 330 below titanium and goldlayers 534 and 536, respectively. This silicon oxide is now the shell328 that surrounds the control module 318 as seen in FIGS. 53, 77 and78.

As a consequence of the removal of the silicon oxide, the surface of thesubstrate 320 previously coated with this material is now exposed. Alsore-exposed are solder plugs 453.

The actual lid 332 is a preformed wafer of metal able to bond with thegold of layer 490. In one version of the invention, lid 332 is formedfrom gold. Lid 332 has a length and width that correspond to the outerperimeter of ring 330. The lid has a thickness of approximately 50microns. A thermal compression bonding process is used to affix the lid332 to the underlying gold layer 536 and, by extension, ring 330. Forease of illustration, in FIGS. 75 and 76 titanium and gold layers 534and 536, respectively, are not illustrated.

Final assembly of electrode array 310 continues with the fitting of thesubstrate-module assemblies in a jig, step not illustrated. The jig isstructured to hold the substrates 320 so they are in a pattern thatcorresponds to the pattern of carrier windows 404. Each substrate 320 ispositioned so that the control module 318 bonded to the substrate is ata location that corresponds to the location of one of the carrierwindows 404.

The carrier-laminate sub-assembly is then disposed over thesubstrate-control module sub-assemblies. As a result of this process,control modules 318 extend through the windows 490 internal to laminatebottom layer 482. The control modules 318 extend at least partiallythrough the carrier windows 404. The portions of shells 328 disposedover the control modules 318 and lids 330 are seated in the spacedefined by middle laminate layer windows 508. These portions of theshells 328 and lids 330 may also extend a short distance into windows508 internal to laminate top layer 486. Owing to the dimensioning of thecomponents, at this time, the outer side surface if each ring 330 isspaced approximately 15 microns or less from the adjacentwindow-defining surfaces of both the carrier 318 and laminate 340.

As a further result of the seating of the carrier-laminate sub-assemblyover the substrate-control module sub-assemblies, the substrate solderplugs 453 extend through rib bores 523, laminate bottom layer openings494 and partially through the middle layer openings 512.

Superstrates 336 are then disposed over the top surface of the laminate340, as represented by FIG. 76. As a consequence of this seating of thesuperstrates 336, each solder plug 471 extends through laminate toplayer openings 518 and partially through the underlying middle layeropening 512. Each superstrate solder plug 471 is therefore inregistration with and contacts an underlying substrate solder plug 453,as seen by FIG. 77. As a further result of the positioning of thesuperstrates 336, each solder plug 472 seats in one of the windows 490integral with laminate top layer 486. Each superstrate solder plug 472contacts the exposed surface of the underlying lid 332.

At this time, the opposed substrates 320 and superstrates 336 arepressed towards each other and heated, (subjected to thermal compressionbonding.) This heat causes solder plugs 453, 471 and 472 to liquefy. Thesolder plugs of each substrate solder plug 453-superstrate solder plugpair 471 bond together. Each of these bonded pairs of solder plugs formsone of the posts 344 that extend from substrate 320, through laminate340 to the superstrate 336. Thus, the posts 344 function as fasteningcomponents that holds each substrate 320 and complementary superstrate336 to the carrier-laminate sub-assembly. During this bonding process, afraction of the solder integral with each superstrate solder plug 471flows over and bonds to the associated capture pad 515. Each post 344therefore also functions as a conductive member over which signals aretransferred to/from, the substrate vias 447, the superstrate vias 462and/or the laminate capture pads.

As mentioned above, as a consequence of the addition of heat in thisstep, superstrate plugs 472 also liquefy. Each solder plug 472 thereforebonds with the underlying lid 332. Further, a portion of solder formingeach plug 472 flows along the outer surface of the adjacent shellcontainment ring 330. Some of this solder reaches the surface of thestep 456 that projects beyond the outer perimeter of containment ring330. The solder forming solder plug 472 therefore, in addition tobonding with the lid 332, bonds with both ring 330 and the exposed faceof gold layer 454 that forms the step 456 around ring 330. Uponrehardening, solder plug 472 forms an additional fastening member thatholds each substrate 320 and complementary superstrate 332 together.

Cable 50 is attached to bond pads located at the proximal end of thelaminate middle layer 484. The method of attaching cable 50 is not partof this invention.

The formation of the posts 344 and the bonding of solder plugs 472 tosubstrate 320 can be considered the completion of the process ofassembling electrode array 310 of this invention. The array 310 may thenbe tested, testing not being part of the present invention.

Once the array 310 is ready for use, the array may be folded forinsertion in a delivery cannula. The array is bent along twolongitudinal axes. A first one of these axes, axis 544 in FIG. 51 iscentered on the line between the carrier tabs 314 that project laterallyfrom bridge sections 382 from the adjacent tabs 315 that project frombridge sections 384. A second one of these axes, axis 546 in FIG. 51, iscentered on the line between the carrier tabs 314 that project laterallyfrom bridge sections 384 and the adjacent tabs that extend from bridgesections 386. Arbitrarily, the array 310 is bent first so bridgesections 382 and the tabs 314 integral therewith are disposed under thebridge sections 384 and the tabs 314 integral therewith. Then, the arrayis bent so bridge sections 386 and the tabs 314 associated therewith aredisposed under bridge sections 382 and the tabs 314 associatedtherewith. This bending, it should be appreciated occurs around thecarrier beams 388. If carrier 314 is formed from elastic material, thisbending of the beams 388 stores potential energy in the beams.

The bending results in the width of the electrode array 310 beingreduced so it can fit in the delivery cannula, (not illustrated and notpart of this invention.) Often the delivery cannula has a lumen with adiameter smaller than the width across the unfolded array.

Once the delivery cannula is positioned over the tissue at which thearray 310 is to be deployed, the array and cannula are separated fromeach other. Again, the exact method is not part of this invention. Forpoint of reference it should be understood that in one array delivery,the delivery cannula may be opened up. In another method of arraydelivery, the cannula is retracted away from the array. In eithermethod, once the array is freed from the constraining cannula, thepotential energy stored by the folded carrier beams 388 releases. Thebeams 388 unfold so as to unbend the whole of the array. Thus the array310 transitions from the folded state to the unfolded state. When thearray 310 so unfolds, the plural rows of electrodes 316 become directedtowards the tissue against which the current is to be flowed.

Current can then be selectively sourced from one set of electrodes 316and sunk to a second set of electrodes. This current flow is targeted toflow through the tissue through which such current flow will have acombination of highly beneficial therapeutic effects and tolerable sideeffects. As discussed above each control module 318 contains componentsfor sourcing and/or sinking different amounts of current to eachelectrode 316 to which the control module is connected. This means each

Electrode array 310 is constructed so that the individual electrodes 316are formed on ridged members, the superstrates 336. Since these backingson which the electrodes 316 are formed are rigid, during delivery of thearray the electrodes themselves are themselves resistant to bending. Forthe same reason, the electrodes 316, when pressed against uneven tissue,are not prone bending. This bending, if allowed to occur, can result indeformation of the components forming the electrodes. If thisdeformation is significant, it can result in fracturing of the componentlayers of the electrode. Such fracturing of the electrode components,can result in electrode malfunction or failure. Again though, array 310is constructed so that the sub-assemblies forming the electrodes 316resist bending. This serves to minimize the possibility that suchbending could be the cause of electrode and, by extension, arraymalfunction.

Similarly, substrates 320 function as rigid backings for the controlmodules 318. The rigidity of an individual substrate 320 makes itunlikely that bending induced stresses can induce unequal and unbalancedstresses on the solder joints that extend from the control module bondpads 422 to the substrate vias 445. The minimization of these stresseson these solder joints results in a like reduction that such stressescan result in the failure of the joints. Such failures, if allowed tooccur, would at least adversely affect the operation of the associatedelectrodes 316.

Moreover, embedded in each substrate 320 are the vias 445 and 447 andtraces 443 that provide the electrical connections that lead to theassociated control module 318. Given the rigid nature of the substrates,these conductive members likewise do not flex. This means that theseconductive members are essentially not subjected flexure inducedstresses that could result in failure causing fractures.

Each substrate 320 and superstrate 336 has at least one major surfacethat is non-porous. The minor surfaces, the side surfaces, of eachsubstrate 320 and superstrate 336 are likewise essentially non-porous.Disposed between the substrate 320 and the superstrate 336 is thelaminate 340. Given that the laminate is formed from layers of LCP, thiscomponent is likewise non-porous. This means that the eachsubstrate-laminate-superstrate stack of components constitute an outercase or shell around the encased control module 318 has a essentially aliquid tight, if not gas tight barrier. Withinsubstrate-laminate-superstrate stack the control module 318 is thenencased on one major face and around the perimeter by ring 330 and lid332. These components are likewise non-porous. Within the ring 330 andlid 332, substantially all of the control module 318 is encased in anon-porous shell.

In sum, three non-porous sub-assemblies substantially encase eachcontrol module 318. Collectively, these assemblies substantiallyeliminate the likelihood that patient's fluids can contact the controlmodule. Likewise the laminate 340 is constructed so as to prevent theconductors 344 from being exposed to the patient. Preventing thesecomponents of the array from exposure to the patient's fluids results ina like reduction in the possibility that such exposure could damagethese components.

It is still a further feature of this invention that thesubstrate-superstrate pairs of this invention are spaced apart from eachother. Thus while the substrate-superstrate pairs both prevent componentbending and block component exposure to bodily fluids, they do notprevent bending of the array 310 around the carrier beams 388. Thisallows electrode array 310 to, as described above, be folded into adelivery cannula with a diameter smaller than width of the array.

Electrode array 310 is thus an assembly that has a large number ofelectrodes 316 that are disposed over a relatively small surface area.In some versions of this invention, the array 310 can have 20 moreelectrodes 316 that are disposed in an area of 3 cm². The currentsourced from/sunk to each electrode can be individually set. This meansarray 310 can be used to provide current flow through underlying tissuethat is precisely targeted. The array 310 can be folded into a widthnarrower than the deployed width of the array. This makes it possible tofold the array into a delivery cannula designed to facilitate thepercutaneous delivery and deployment of the array. Further, thecomponents forming the array define plural non-porous barrier layersaround at least the array control modules. This feature of the arraysubstantially eliminates the possibility that body fluid can come intocontact with the arrays and the attendant damage caused by such contact.

VII. Alternative Embodiments

It should be appreciated that the foregoing is directed to specificconstructions and specific methods of assembly of the electrode arraysof this invention.

The features of electrode arrays 40, 40 a, 40 b and 310 may beselectively combined. For example, in an alternative version of theinvention, the carrier assembly may consist of the Nitinol (metal) frameencased in parylene. In this version of the invention, the controlmodules may be mounted to the rigid backings and the electrodes maysimilarly be formed on rigid backings.

Also there is no requirement that in all versions of the invention thateach electrode array include plural control modules. In some versions ofthe invention, it may only be necessary to provide the electrode arraywith a single carrier-embedded control module. Electrode array 310 isdescribed as having a pair of electrodes connected to each controlmodule 318. In alternative versions of this embodiment of the invention,each control module may include the components that source current toand/or sink current from, one or three or more electrodes. It shouldtherefore be appreciated that there is no requirement that in eachversion of the invention, the control module that sources current to orwhich current is sunk from an electrode be mounted to the carrier so asto subtend the area occupied by the electrode. Thus it is contemplatedthat in some versions of the invention, the control modules may bemounted in locations in the carrier that are spaced away from thelocations over which the electrodes are formed.

Also, it may be necessary to provide an electrode array of thisinvention with one or more control circuits that, owing to their design,cannot be assembled into carrier-implantable control modules. In theseversions of the invention one or more of these additional controlmodules may be mounted to either the active or passive side of theelectrode array.

Similarly, the functions of the embedded control modules are not limitedto modules that source/sink current to the electrodes. Some controlmodules may contain components useful for processing signals received bythe electrodes. Thus when a particular electrode does not function as acurrent source or sink, these components internal to the control moduleprocess the potential measured by the electrode so these potentialmeasurements can be further processed by other components. Whether ornot a specific control module contains components to source currentand/or sink current and/or process a potential measured by an electrodeor electrodes is a function of the specific electrode array. Still otheralternative control modules may not include any of these processingcomponents. These control modules may include devices for storing thecharge that is used to flow current between the electrodes. Othercontrol modules may include components for providing connections betweenthe electrode array 40 and components off the array.

Likewise, the shapes of the components may be different from what hasbeen described. Thus, while in the described versions of the invention,the electrodes are located on tabs that are separate from thesurrounding sections of the carrier, this is not required in allversions of the invention. There is no requirement that in all versionsof the invention, the electrodes be arranged in the row by column array.Thus, for some applications of the invention, the electrodes may bearranged in a single column on the carrier.

Similarly, there is no requirement that in all versions of theinvention, the control modules be seated in windows that extendcompletely through the carrier. In some versions of the invention, thecarrier may be formed with recesses that do not extend all the waythrough the carrier. In these versions of the invention, the materialforming the passivation frame is applied to the surfaces of the carrierthat form the bases of the recesses. Thus, in these versions of theinvention, the material forming the passivation frame forms a shell thatinsulating frame between the die forming control module 44 and thesurrounding carrier.

Likewise, there is no requirement that in all versions of the invention,the electrode array be formed from the disclosed components. Forexample, there is no requirement that in all versions of the inventionthe carrier be formed from material that is superelastic or evenmaterial that is deformable. In some versions of the invention, thecarrier can be formed from material that is simply flexible. This isusefully when constructing an electrode array that is to be placedagainst irregularly shaped tissue. In these and other versions of theinvention, the carrier therefore may not be formed from metal or otherelectrically conductive material. Thus, the carrier may formed from aplastic such as silicone or a polyamide. In versions of the inventionwherein the carrier is not formed from electrically conductive material,the need to provide an electrical insulating shell and/or frame betweenthe control module and the carrier may be eliminated.

Similarly, for example, ribs 521 may not be needed to “fill in” troughsin the carrier-laminate assembly that may form as a consequence ofadjacent layers LCP bonding together where the carrier is not present.Alternatively, the ribs 521 may be formed by depositing silicon oxide orother filler material in the troughs. Then once the ribs are formed,portions of electrically insulating laminate forming material and theribs themselves are removed to define the through bores in which theposts are subsequently formed.

The number of conductors extending to the electrodes 42 and 316 and tothe embedded control modules 44 and 318 should likewise be recognized asillustrative, not limiting. In some versions of the invention, to ensurecharging balancing across a single electrode 42 plural vias or otherconductors may extend from the control module to that electrode.Likewise, in some versions of the invention only a single conductor orthree or more conductors may extend to the embedded control module. Forexample, in some versions of the invention, one conductor may serve as acommon power bus. This bus serves as the conductor over which power, andonly power, is distributed to each of the control modules 44. One ormore additional conductors function as the bus over which controlsignals are broadcast to the control modules and data are received backfrom the control modules.

In the illustrated version of the invention, conductors 46 and 48 thatextend to the embedded control module are shown as stacked one below theother. This is likewise understood to be for purposes of illustrationand not limiting. In some versions of the invention, if the conductorsare positioned on different heights they may not overlap each other. Insome versions of the inventions plural conductors that are located atthe same height, (that are disposed over the same insulating layer) mayextend to one or more common control members.

Likewise, in some versions of the invention, some of the conductors mayextend directly to the electrodes. Also, it may be desirable to providevias that connect the conductors located at different heights, (that aredisposed over different insulating layers,) with vias. These vias areformed by employing variations of the above described fabricationtechniques. Thus, after an insulating layer is formed over a conductor,a hole is formed in the layer so as to terminate over the conductor. Thenext level conductor is formed over the outer insulating layer. As partof this process of forming this conductor, some of the metal forming theconductor flows into this hole to form a conductor-to-conductor via.

The process steps performed to fabricate an electrode array of thisinvention likewise may differ from what has been described. Thus, theprocess steps of the different versions of the invention may beselectively combined. Also, preformed sheets of insulating material andor conductors that are partially or fully shaped to their final formsmay be used to form, respectively, one or more of the insulating layersor conductors of the invention.

Similarly, the die forming the control module 44 may not simply beseated in the associated shell. In some versions of the invention, alayer of parylene may be applied to the inner surfaces of the walls ofthe shell prior to the placement of the die. Once the parylene layer isestablished, the die is placed in the shell. Given the elastic nature ofthis parylene layer, the parylene layer functions as shock absorber thatreduces the mechanical shock and vibrations to which the control moduleis exposed. Alternatively, or in addition to the parylene, an adhesivemay be applied to the die so as to secure the control module 44 in theshell.

Likewise, an adhesive may be applied to the outer surface of the shells84. When the shells are seated in the windows 81 of the carrier, thisadhesive forms a bond between the shell 84 and the adjacent frame 81 ofwindow-defining surface of the carrier 81.

Similarly, there is no requirement that all the features of electrodearray 310 of this invention be used together. Some versions of theinvention may include the described superstrates that function as rigidbackings for the associated electrodes. These versions of the inventionmay not include the underlying substrates. Likewise, some electrodearrays may include the described substrates upon which the controlmodules are mounted and not the superstrates for providing rigidbackings for the electrodes.

Alternatively, in some versions of the array rigid backings may performtwo functions. As seen in FIG. 78, in these versions of the invention,the electrodes 317 may be formed on one surface of the ceramic member,here substrate 321, while the control modules 318 and theircomplementary non-porous shell (or shells) are disposed on the opposedsurface. In these versions of the invention these electrode-rigidbacking-control module assemblies may be mounted to the carrier so thatthe encased control modules are seated in windows formed in the carrier.In one version of this embodiment, the rigid backings are only providedon one side of the carrier. In these versions of the structures similarto posts 344 both hold the backings to the carrier and provide theconductive paths between the carrier conductors and the control modules.The posts may extend to small ceramic islands on the opposed side of thecarrier. One advantage of this versions of the invention the connectionsbetween a control module and the electrode (or electrodes) to which itis connected can be by vias 542 that extend through the common rigidbacking, substrate 321 in FIG. 78. Another advantage of this version ofthe invention is that eliminates the need to provide both sides of thecarrier with rigid components that have the surface area of the rigidbackings.

In an alternative version of this embodiment of the invention, theversion seen in FIG. 78, the electrode array may still have a second setof rigid backings, here superstrates 336. These rigid backings arelocated on the surface of the carrier opposite the surface on which thebackings carrying both the electrodes 317 and control modules 318 aremounted. The rigid backings of this second set of backings support theirown electrodes 316. Thus, in this version of the invention isconstructed so that electrodes disposed on spaced apart rigid backingsare located on both sides of the carrier.

Also, there may not be any requirement to provide an electrode arrayswith a superelastic carrier. These carrier, for example may not beneeded for arrays that are not intended for percutaneous insertion. Inthese versions of the invention, the control modules may simply beembedded in a flexible, electrically insulating carrier. Again, in orderto protect the control modules from the environment, the modules may beencased in one or more non-porous caps.

Further, should the insulating carrier be formed from a laminate, suchas LCP, there is no requirement in all versions of the invention thelaminate have three layers. In alternative assembles, the laminate mayconsist of two or four or more layers.

Additional variations in the components forming the electrode array ofthis invention are also possible. For example, the rigid backings towhich the electrodes 316 and control modules 318 are mounted need notalways be made of ceramic. These backings can be formed of othermaterial such as plastics into which conductors can be embedded.Similarly, silicon oxide need not always be the make-up material thatforms the non-porous conformal shell disposed over the control modules318. In other versions of the invention, other coatings, such as epoxiesand polymers may function as the shell-forming coating. Likewise, theshell may not always include a conformal coating. In some versions ofthe invention, the shell may include a preformed non-porous cap that issimply fitted in place on the rigid backing around the control module318. Thus, in some versions of the invention ring 330 and lid 332,without the filler silicon oxide, may form the non-porous cap portion ofthe shell bounded to the rigid backing to which the control module isattached. In these versions of the invention, the rigid backing, thering, and lid would collectively form the non-porous shell around thecontrol module 318.

Therefore, it is the goal of the appended claims to cover all suchmodifications and variations that come within the true spirit and scopeof this invention.

What is claimed is:
 1. A method of assembling an implantable electrodearray, said method including the steps of: packaging at least onecontrol module according to the steps of: forming a containment ring ona first surface of a substrate; mounting a control module to the firstsurface of the substrate so that the control module is disposed in thecontainment ring; applying a coating to the first surface of thesubstrate so that the coating is disposed in the containment ring aroundthe control module so that the coating forms a non-porous shell in thecontainment ring around the control module; bonding a lid over thecontainment ring so that the lid extends over the control module and theshell so as to form at least one packaged control module embedding theat least one packaged control module in a flexible carrier; andelectrically connecting the at least one packaged control module to atleast one electrode that is disposed over or embedded in the flexiblecarrier.
 2. The method of assembling an implantable electrode array ofclaim 1, wherein: in said step of packaging the at least one controlmodule: said step of forming a containment ring of the first surface ofthe substrate is performed by forming the containment ring so that thecontainment ring is at least partially located inwardly of an outerperimeter of the containment ring; in said step of applying a coating tothe first surface of the substrate, the coating is applied to portionsof the first surface located outside of the containment ring; and aftersaid step of applying a coating to the first surface of the substrate,removing portions of the coating located outside of the containment ringfrom the substrate; and in said step of embedding the at least onepackaged control module in the flexible carrier, the packaged controlmodule is embedded in the carrier so that the control module, the shelland the containment ring are disposed in the carrier and the firstsurface of first surface of the substrate is located adjacent an outersurface of the flexible carrier.
 3. The method of assembling animplantable electrode array of claim 1, wherein: in said step formingthe containment ring, the containment ring is formed so that when thecontrol module is mounted to the first surface of said substrate, thecontainment ring extends above the control module; in said step ofapplying the coating to the first surface of the substrate, the coatingis applied to extend over the control module so that, after said step ofbonding the lid over the containment ring, a portion of the shell islocated between the control module and the lid.
 4. The method ofassembling an implantable electrode array of claim 1, wherein: in saidstep forming the containment ring, the containment ring is formed sothat when the control module is mounted to the first surface of saidsubstrate, the containment ring extends above the control module; insaid step of applying the coating to the first surface of the substrate,the coating is applied to extend over both the containment ring and thecontrol module; after said step of applying the coating to the firststep of the control module, a portion of the coating over thecontainment ring is removed to expose a face of containment ring; and insaid step of bonding a lid over the containment ring, the lid is bondedto the exposed face of the containment ring so that so that, after saidstep of bonding the lid over the containment ring, a portion of theshell is located between the control module and the lid.
 5. The methodof assembling an implantable electrode array of claim 1, wherein: insaid step of embedding the at least one packaged control module in theflexible carrier, the at least one packaged control module is embeddedin the flexible carrier so that the substrate is located adjacent afirst surface of the flexible carrier; and in said step of electricallyconnecting the at least one packaged electrode to the at least at leastone electrode, the at least one packaged control module is connected toan electrode disposed over or embedded in a second surface of theflexible carrier, the second surface being opposite the first surface ofthe flexible carrier.
 6. The method of assembling an implantableelectrode array of claim 1, further including the step of forming atleast one electrode on a superstrate and wherein: in said step ofembedding the at least one packaged control module in the flexiblecarrier, the at least one packaged control module is embedded in theflexible carrier so that the substrate is located adjacent a firstsurface of the flexible carrier; and said step of electricallyconnecting the at least one electrode to the at least one packagedcontrol module is performed by mounting the superstrate with the atleast one electrode to a second surface of the flexible carrier, thesecond surface being opposite the first surface, and electricallyconnecting the at least one electrode on the superstrate to the controlmodule.
 7. The method of assembling an implantable electrode array ofclaim 6 wherein, in said step of mounting the superstrate to the secondsurface of the flexible carrier, the superstrate is secured to the lidof the packaged control module.
 8. The method of assembling animplantable electrode array of claim 1, wherein: in said step ofembedding the at least one packaged control module in the flexiblecarrier, the at least one packaged control module is embedded in theflexible carrier so that the substrate is located adjacent a firstsurface of the flexible carrier; in said of forming the containment ringon the substrate, the containment ring is formed on a substrate that, inaddition to the containment ring, the substrate includes at least oneelectrically conductive post that extends outwardly from the firstsurface of the substrate; in said step of mounting the control module tothe first surface of the substrate, the control module is mounted to thesubstrate so as to establish at least one electrical connection betweenthe control module and the at least one post; in said step of embeddingthe at least one packaged control module in the flexible carrier, the atleast one post is embedded in the flexible carrier; and said step ofelectrically connecting the at least one packaged control module to theat least one electrode is formed by placing at least one electrode on asecond surface of the flexible carrier, the second surface beingopposite the first surface and electrically connecting the at least onepost to the at least one electrode.
 9. The method of assembling animplantable electrode array of claim 8, wherein in said step of formingthe containment ring on the first surface of the substrate, the at leastone post that extends outwardly from the substrate is at least partiallysimultaneously formed.
 10. The method of assembling an implantableelectrode array of claim 1, wherein: in said step of mounting thecontrol module to the first surface of the substrate, the control moduleis mounted to the substrate so the control module is spaced away fromthe first surface of the substrate; and in said step of applying acoating to the first surface of the substrate, the coating is applied soas to disposed between the first surface of the substrate and thecontrol module so that a portion of the shell is located between thefirst surface of the substrate and the control module.
 11. The method ofassembling an implantable electrode array of claim 1, wherein: in saidstep of mounting the control module to the first surface of thesubstrate, the control module is mounted to a substrate that has asecond surface opposite the first surface; and in said step ofelectrically connecting the at least one packaged control module to atleast one electrode, the at least one packaged control module iselectrically connected to an electrode disposed on the second surface ofthe substrate.